Preliminary Clinical Studies of Bioceramic in Periodontal Osseous Defects*
molar. In the other two cases, a defect was found at the interproximal area of the maxillary first molar and sec ond premolar in one case, and in the other on the distal aspect of the mandibular second premolar with missing distal proximal tooth. Prior to implant procedure, all patients received root planing and instructions on oral hygiene. A l l carious lesions were repaired and, i f needed, missing teeth were replaced. The following pre- and postoperative proce dures were also undertaken and recorded: 1. A n amalgam marker was placed on the tooth sur face as a reference point. If the involved tooth had an existing amalgam or gold restoration, the most apical basal portion of this restorative material was utilized as a reference point. Using a paralleling technique de scribed by Updegrave, pocket depth was sound mea sured with the aid of a stainless steel measuring gauge (machine fabricated, accurate to 1 mm) inserted in the defect. For accurate comparative measurements, an xray film holder was modified for each patient so that it could be stabilized in position, or be removed and re placed in the same position. This was modified by the use of self-curing acrylic material placed on the biting rim of the holder where imprint of the occlusal surface of the teeth was made. 2. For gingival evaluation, gingival index (GI) scoring devised by Löe and Silness was used. However, this system was modified by scoring only the buccal and lingual gingivae in a given area. The gingivae were given a score of 0 to 3 according to the severity of inflamma tion. The values of the buccal and lingual scores were added and divided by 2 giving the G I mean for one particular implant site. This scoring was done pre- and postoperatively. 3. Blood chemistries (SMA-12) were also conducted for each patient before and at time of postoperative evaluation. This was treated statistically with Student's t test for any possible significant change. Surgery was performed under local anesthesia using 2% Xylocaine mixed with epinephrine (1:100,000).§ W i t h a sulcular incision around the involved tooth, followed by a releasing modified vertical incision at some distance from the implant site, a full thickness mucoperiosteal flap was reflected to expose the bony defect (Fig. 1). For easy reflection a similar vertical incision was made also on the lingual side. In one case, the incision was made continuing through the interdental papilla. Hence, the incision was directed at the implant site. To permit total closure following placement of the implant, an attempt was made to obtain adequate papillary tissue during this incisional procedure. N o osseous recontouring was at tempted, but intramarrow penetration was performed in the defect to improve communication with the marow spaces. A thorough root planing with hand instruments
by
E D M U N D O B . N E R Y , D.M.D.† K E N N E T H L . L Y N C H , PH.D.‡ BIOCERAMIC MATERIALS have been used successfully in the repair or reconstruction of different forms of osseous defects in "normal" healthy animals. These defects were either surgically created or induced. Previous ex periments on periodontal osseous defects in animals have shown that tricalcium phosphate ceramic was well tol erated by the tissue. Bone grew into the pores and repair of the periodontium was clearly demonstrated. How ever, one very important question arises: that is, will this ceramic react the same in naturally occurring osseous defects, and allow bone and soft tissue ingrowth to occur in its pores and create a strong biomechanical attachment with the periodontium? T o our knowledge, this has not been demonstrated in clinical conditions. The purpose of this study therefore was to initiate this type of inves tigation. Initially an attempt was made to investigate the effects of porous tricalcium phosphate ceramic in the repair of naturally occurring periodontal osseous defects on a clinical level involving the assessment of the gingival tissues at the implant site, the change in the pocket depth measurement and the blood chemistries.
10
1-8
5, 6
11
MATERIALS A N D METHODS
Since this was a pilot study, only six male adult patients were selected on a voluntary basis. The criteria for selection were: (1) The patient should have no evi dence of endocrine disorders and/or blood dyscrasias; (2) the patient should be free of mycotic, bacterial or viral infection; and (3) the patient should present clini cally and radiographically localized two or three wall infrabony defects as classified by Goldman and Cohen, found either on the mesial or distal aspect of a tooth. In this report, in four out of six cases, the defect was found on the distal edentulous aspect of the mandibular second 9
* Supported by the Medical Research Service of the Veterans Administration. † Chief, Dental Research Section, Dental Service, Veterans Admin istration Center, Wood (Milwaukee), Wisconsin and Assistant Clinical Professor in Periodontics, Marquette University School of Dentistry, Milwaukee, Wisconsin. ‡ Research Investigator, Veterans Administration Center, Wood (Milwaukee), Wisconsin and Head Orthopedic Research Laboratory and Lecturer, Orthopedic Surgery, Department of Orthopedic Surgery, The Medical College of Wisconsin, Milwaukee.
§ Astra Pharmaceutical Products, Inc., Worchester, Mass 01606.
523
524
J. Periodontol. October, 1978
Nery, Lynch
F I G U R E 1 A . Drawing illustration showing a vertical releasing incision made at some distance from the defect to obtain adequate soft tissue coverage. B . Viewing occlusally, a similar incision was made on the lingual.
and removal of "chronic granulation tissue" found in the defect was also instituted. This was followed by irrigation with normal saline solution. The prepared ceramic, with pore size of 400 to 500 micrometers and 50% pore volume, was then crushed to smaller pieces (Fig. 2) and lightly packed into the defect with an amalgam plugger. Care was taken not to overfill the defect. Bleeding was induced in order to cover the ceramic material with a blood clot. The flap was returned to the original position, being sure that the ceramic was completely covered. It was sutured with 4-0 silk interrupted sutures. A perio dontal dressing* was also used to protect the flap from possible displacement. Postoperatively, the patients were given oral penicillin (250 mg), one tablet three times daily for 7 days, and were maintained on a soft diet for 3 days. The sutures and dressing were removed 2 weeks postoperatively. N o probing was done for a period of 2 months, but these patients were seen for a checkup and reinforcement of oral hygiene every 2 weeks. Two patients, however, did not make these visits. Since difficulty was encountered in recalling these patients for a specific time interval, a selected postoper ative evaluation time was simply assigned to one patient; that is, only one patient was designated for 2 months postoperative evaluation time, the other for 4 months etc. The postoperative evaluation time ranges from 2 to 16 months. RESULTS
Postoperative healing was uneventful except for one patient whose ceramic implant exfoliated after a period of 3 weeks, which was apparently due to inadequate soft tissue coverage during wound closure. Because complete coverage of the implant was not obtained, the tissue became vulnerable to infection. This patient was there fore eliminated from the study. * Coe Pak, Coe Laboratories, Inc., Chicago, IL 60658.
F I G U R E 2 A . Porous tricalcium phosphate ceramic crushed into smaller pieces ready for implantation. B . This is compared to the original pellet form.
Gingival Index The gingival index, as summarized in Table 1, shows that the gingival tissue healed within a period of 2 months with no evidence of adverse inflammatory re sponse. It appears that this condition was maintained throughout the experimental period, except for one pa tient who demonstrated slight inflammation of the gin givae at the implant site when examined 12 months postoperatively. This was due to poor oral hygiene, but reinforcement of proper home care instructions reversed the condition. The inflammation observed following sur gery was the result of surgical trauma which subsided in approximately 3 to 4 weeks. Pocket Depth Radiographically, Table 1 shows that there was a significant coronal increase in bone height when mea sured from the base of the infrabony defect to the base
Volume 49 Number 10
Bioceramic in Periodontal Osseous Defects 525 TABLE 1. Pre- and Postoperative Gingival Index (GI) and Pocket Depth (PD) for Five Patients B
A*
D
C
E
Mean ± SD
Pre
2 Months
Pre
4 Months
Pre
6 Months
Pre
12 Months
Pre
16 Months
Pre
Post
0 6
0 3
0 11
0 9
0 14
0 4
1 11
1 5
0 12
0 7
0.20 ± 0.44 10.80 ± 2.94
0.20 ± 0.44 5.60 ± 2.40†
GI (0-3) PD (mm)
* Patients, † x gain = 5.20 mm.
F I G U R E 3 A . Preoperative radiograph showing measuring gauge inserted in osseous defect distal to the mandibular 2nd molar. B . Sixteen months postoperatively the defect (arrow) appears to be well filled to the alveolar crest with presumably new bone and/ or ceramic material, as illustrated with the measuring gauge. o f the a m a l g a m m a r k e r ( F i g . 3 A a n d B ) . T h e preopera t i v e m e a n v a l u e w a s 10.8 m m a n d p o s t o p e r a t i v e l y 5.6 m m , g i v i n g a m e a n g a i n o r fill o f 5 . 2 m m . I t s h o u l d b e noted that the measurement
FIGURE 4A. Three-walled infrabony defect on the mesial aspect of the right maxillary 1st molar (arrow) prior to ceramic implan tation. B . Two months postoperatively the ceramic (arrow) ap pears to blend with the surrounding osseous tissues.
change (P < 0.01). Based on the data obtained from the Technicon Instrument Corporation (Tarrytown, N Y ) ; S M A - 1 2 normal range, the postoperative mean value falls within this range.
s h o w n was made from the
base o f the defect to the a m a l g a m m a r k e r a n d n o t f r o m
DISCUSSION
the base o f t h e defect t o t h e a l v e o l a r crest, n o r t o t h e
Although we realize this study had a very limited number of subjects and limited criteria for evaluation, the results were promising. Clinically and hematologically we have shown that porous tricalcium phosphate ceramic was well tolerated by human tissue when used as an implant material for the repair of periodontal osseous defects. The G I score seems to indicate that there was no inflammatory response during the experimental period except for the immediate postsurgical trauma. Since no histological evaluation was made in this study, inflammatory cell infiltrate could not be accounted for at this time. For pocket depth measurement, an increase i n bone height was evident radiographically when measured from the base of the pocket to the amalgam marker. However, as yet it has not been determined whether this
gingival margin. I n e x a m i n i n g the radiographs, w e have noted also that the c e r a m i c m a t e r i a l seems to b l e n d w i t h the s u r r o u n d i n g bone, i n d i c a t i n g that the radiographic density is p r o b a b l y the same i n b o t h (Figs. 4 A a n d 4 B ) . A t the interface between the root surface a n dthe ceramic, the p e r i o d o n t a l l i g a m e n t space w a s difficult to delineate, p r o b a b l y sug gesting that there w a s inadequate space f o r d e v e l o p m e n t o f the entire w i d t h o f the ligament. H o w e v e r , the possi b i l i t y o f n e w soft t i s s u e a t t a c h m e n t
i n this area
cannot
be r u l e d out. Blood
Chemistries
A s illustrated i n T a b l e 2, the p r e - a n d postoperative S M A - 1 2 b l o o d chemistry study showed n o significant
526
J. Periodontol. October, 1978
Nery, Lynch TABLE 2.
Pre- and Postoperative Blood Chemistry Values for Five Patients
Patients (Male Adults) A
Blood test (SMA-12) Pre
2 Mon
Pre
T.P. (gm%) Alb (gm%)
6.90 4.60
8.00 5.50
7.50 5.20
C A (mg%) Inor Phos (mg%) Chol (mg%) Glu (mg%) B U N (mg%) Uric Acid (mg%) Creat (mg%) Tot Bili (mg%) Alk Phos (mU/ml) SGOT (mU/ ml)
8.60 3.60
10.00 3.60
9.70 3.40
2.95 80 13 7.60
3.15 90 12 6.80
2.15 80 13 5.00
1.10 0.40
1.30 0.70
1.20 1.20
D
C
B
M e a n ± S D ( l SD)
Pre
6 Mon
Pre
12 Mon
7.50 5.70
7.60 5.50
7.50 6.00
7.20 5.10
7.20 4.80
7.10 4.80
9.50 2.70
10.30 3.60
10.50 3.40
9.70 2.80
9.80 2.60
9.50 2.80
1.40 1.80 100 90 10 11 5.80 5.10
1.50 90 13 5.80
2.40 85 14 7.50
2.15 95 20 7.60
1.30 0.90
1.05 0.90
1.10 0.70
1.10 0.50
4 Mon
1.00 0.70
50
50
50
55
60
20.00
20.50
20.00
20.00 25.00
t*
E
Pre
Normal Range†
Pre
Post
7.00 4.80
7.25 ± 0.28 5.04 ± 0.35
7.44 ± 0.38 5.36 ± 0.54
0.78 1.52
6.00-8.50 3.50-5.20
8.90 3.40
9.56 ± 0.62 3.24 ± 0 . 4 1
9.74 ± 0.59 3.14 ± 0 . 4 6
0.54 0.48
8.50-10.50 2.50-4.50
2.10 ± 0 . 6 3 98 ± 12.36 12.60 ± 4.56 6.38 ± 0.96
0.86 2.71 0.34 0.44
1.50-3.10 55-135 10-26 4.00-9.00
1.11 ± 0 . 1 2 0.64 ± 0 . 1 9
0.62 1.18
0.70-1.40 0.20-1.20
0.34
30-115
0.16
7.00-40.00
16 Mon
2.05 1.90 2.19 ± 0 . 5 6 89 ± 12.44 110 115 8 13.40 ± 1.81 16 6.40 6,60 6.46 ± 1.11 1.10 0.90
Value
1.10 0.40
1.16 ± 0 . 8 9 0.82 ± 0.29
45
70
65
60
70
57 ± 8.36
25.00
15.00
35.00
45.00
25.00 25.00 ± 11.72
58 ± 10.36 25.10 ± 6 . 0 2
*t = 4.60; P< 0.01. † Normal range taken from Technicon Instruments Corp., Tarrytown, N Y 10591.
increase was made up of bone and/or ceramic. In as sessing the repaired pockets, it was not possible to deter mine whether we have a new soft tissue attachment between the root surface and the periodontium. Only histologic studies, which are being initiated i n our labo ratory at this time, could furnish the answer to these problems. Hematologically, it is quite clear that the blood chem istries ( S M A - 1 2 ) were not affected by the ceramic im plant, indicating that the material causes no ill effects to the vital organs (especially liver and kidney), nor was there an alteration i n the metabolism of calcium and phosphorous, or the enzyme systems. O f course, other factors may be involved which are beyond the scope of this investigation. Throughout the experimental period it appears that porous tricalcium phosphate ceramic is nontoxic to hu man tissue and could be used as a potential alternative to bone grafting. Finally, it should be noted that all of the patients remained free of any clinical complaints following subsidence of the immediate postsurgical dis comfort. Future work is directed to histological evalua tion of the implant and implant site correlated with clinical findings. SUMMARY
In six patients, porous tricalcium phosphate ceramic (400 to 500 micrometer pore diameter and 50% pore volume) was used to repair naturally occurring perio dontal osseous defects. These patients were evaluated clinically, radiographically and hematologically. The clinical evaluation indicated that there was no adverse
inflammatory response at the implant site except the anticipated immediate postsurgical trauma. Radiograph ically, there was a significant increase i n bone height with a mean gain of 5.2 mm. Whether or not this gain consisted of bone and/or ceramic is yet to be conclusively determined. The S M A - 1 2 blood chemistry study re vealed that no significant change occurred pre- or post operatively (P< 0.01). Although the number of patients i n our study was limited, the results are very promising. The ceramic is nontoxic to human tissue and repair of the periodontium is most likely obtainable, the desired objective being the restoration of the natural state of the periodontium. ACKNOWLEDGMENTS
The authors wish to thank Dr. Walter Hirthe, Marquette University College of Engineering, for supplying us with the ceramic material; Dr. Vernon D. Foshager for his comments and criticism; Carole Russell-Hilmer for preparing the drawing illustration; and Catherine A. Walther for her editorial assist ance. REFERENCES
1. Bhaskar, S. N., Brody, J. M., Getter, L., Gromer, M . F., and Driskell, T. D.: Biodegradable ceramic implants in bone. Oral Surg 32: 336, 1971. 2. Tennery, V. J., and Driskell, T. D.: SEM studies of boneceramic interfaces in calcium phosphate resorbable ceramic (abstr.). Ceramic Bulletin, Society Symposium on Biomaterial, p. 430, 1973. 3. Driskell, T. D., Hassler, C. R., Tennery, V. M., McCoy, L. R., and Clark, W. J.: Resorbable ceramics: A potential alternative to bone grafting (abstr.). J Dent Res 52: 123, 1973. 4. Topazian, R. G., Hammer, W. B., Talbert, C. O., and Hulbert, S. F.: The use of ceramics in augmentation and
Volume 49 Number 10
Bioceramic in Periodontal Osseous Defects 527
replacement of portions of the mandible. J Biomed Mater Res 6:311, 1972. 5. Levin, M . P., Getter, L., Cutright, D. E., and Bhaskar, S. N.: Biodegradable ceramic in periodontal defects. Oral Surg 38: 344, 1974. 6. Nery, E. B., Lynch, K. L., Hirthe, W. M., and Mueller, K. H.: Bioceramic implants in surgically produced infrabony defects. J Periodontol 46: 328, 1975. 7. Pedersen, K . N.: Rebuilding of deficient edentulous al veolar ridge with porous ceramic implants. Int J Oral Surg 5: 133, 1976.
8. Lynch, K . L., Mueller, K . H., Hubbard, W. G., and Hirthe, W. M . : Porous physiological calcium phosphates in orthopedic biomaterials. Clin Orthop (in press). 9. Goldman, H . M., and Cohen, D. W.: The infrabony pocket: Classification and treatment. J Periodontol 29: 272, 1958. 10. Updegrave, W. J.: Paralleling extension—cone tech nique in intraoral radiography. Oral Surg 4: 1250, 1951. 11. Löe, H., and Silness, J.: Periodontal disease in preg nancy: Prevalence and severity. Acta Odontol Scand 21: 533, 1963.
Announcements P O S T G R A D U A T E D E N T A L P R O G R A M , A L B E R T EINSTEIN C O L L E G E O F MEDICINE The following courses are available during the academic year, 1978-1979 OCCLUSION DPD 36 (Coronal Reshaping: A Practical Treatment for Occlusal Problems of the Adult), IRA FRANKLIN ROSS, D.D.S., Wednesdays, October 25, and November 1, 1978, $160. PERIODONTIC REVIEW COURSE DPD 43,
M A R V I N N. O K U N , D.D.S.,
IRVING Y U D K O F F , D.D.S., BERTRAM S. BILDNER, D.D.S., and E D
P O S T G R A D U A T E C O U R S E IN H E A D A N D NECK ANATOMY A four-day course entitled "The Alton D. Brashear Postgraduate Course in Head and Neck Anatomy" will be held at the Medical College of Virginia, Department of Anatomy, January 15-18, 1979. Fresh specimens (unpreserved) whenever possible are used in the dissections and individual surgical approaches are welcomed. Lectures and demonstrations will augment the laboratory work. The course is approved for 40 elective hours by the American Academy of General Practice and Academy of General Dentistry.
MUND D. D'ONOFRIO, D.M.D., Wednesday, November 8, 1978, $70. PERIODONTICS
DPD 66 (A 20 Session Periodontics Participation
Course) M A R V I N N. O K U N , D.D.S., IRVING Y U D K O F F , D.D.S., BER
Further information may be obtained from Dr. Hugo R. Seibel, Department of Anatomy, Medical College of Virginia, Richmond, Virginia 23298.
TRAM S. BILDNER, D.D.S., E D M U N D D. D ' O N O F R I O , D.M.D., JOSEPH F. Puccio, D.D.S., K A L M E N
D. EINBINDER, D.D.S., D A N I E L M .
NACHMANOFF, D.D.S., and DAVID L. RAUCHER, D.D.S., 20 Wednes days, commencing January 3, 1979 through May 16, 1979, $2,100 (including manuals). TEMPOROMANDIBULAR JOINT DISORDERS DPD 86, J O H N R. VAROSCAK,
D.D.S., Friday, March 23, 1979, $70. PERIODONTICS DPD 94, NINETEENTH ANNIVERSARY A L U M N I L E C T U R E , T H E D R . Z A C H A R Y D E M B O M E M O R I A L L E C T U R E (Methods of Treat
ment of Periodontal Pockets), SIGURD P. RAMFJORD, D.D.S., Ph.D., Wednesday, April 25, 1979, $70. RECONSTRUCTIVE
PERIODONTAL
SURGERY
DPD
102,
MORRIS
P.
R U B E N , D.D.S., Wednesday, May 16, 1979, $70. POSTGRADUATE EXTENSION PROGRAM (off
campus courses): Faculty
members of the Postgraduate Dental Program, who are specialists in their fields, are available for short, intensive courses that can be given in various cities if a sufficient number of practitioners evince interest. If clinical facilities are available, these courses can be a combination of lectures and demonstrations. For further information and application, write to: Dr. Irving Yud koff, Director, Postgraduate Dental Program, Albert Einstein College of Medicine, 1165 Morris Park Avenue, Bronx, New York 10461.
I N T E R N A T I O N A L SYMPOSIUM O N R E C E N T A D V A N C E S IN CLINICAL PERIODONTOLOGY Tel-Aviv University School of Dental Medicine and Toronto A l umni Chapter, Alpha Omega Fraternity announce the International Symposium on Recent Advances in Clinical Periodontology, October 25 and 26, 1978, Tel-Aviv University Dental School, Israel. Main subjects will be presented by Prof. JAN E G E L B E R G , Depart ment of Periodontology, School of Dentistry, Malmo, Sweden; Prof. M A X A. LISTGARTEN, Department of Periodontics, Center for Oral Health Research and School of Dental Medicine, University of Penn sylvania. Some titles: Efficiency of Plaque Control Programs for Adult Patients, Subgingival Scaling vs. Periodontal Surgery, Reattachment Potentials of the Periodontal Tissues, Maintenance Therapy and LongTerm Prognosis after Periodontal Treatment, Development and Struc ture of Periodontal Tissues, Development and Structure of the Perio dontal Flora, Current Views on the Histopathology of the Gingival Lesion, The Gingival Sulcus and Pocket: Histological and Clinical Considerations. For further information contact: The Secretary, School of Dental Medicine, Tel-Aviv University, Ramat-Aviv, Tel-Aviv, Israel, or Dr. Hart Levin, 2006 Bathurst St., Toronto, Ontario, M5P 3L1, Canada, (416) 781-2006.
molar. In the other two cases, a defect was found at the interproximal area of the maxillary first molar and sec ond premolar in one case, and in the other on the distal aspect of the mandibular second premolar with missing distal proximal tooth. Prior to implant procedure, all patients received root planing and instructions on oral hygiene. A l l carious lesions were repaired and, i f needed, missing teeth were replaced. The following pre- and postoperative proce dures were also undertaken and recorded: 1. A n amalgam marker was placed on the tooth sur face as a reference point. If the involved tooth had an existing amalgam or gold restoration, the most apical basal portion of this restorative material was utilized as a reference point. Using a paralleling technique de scribed by Updegrave, pocket depth was sound mea sured with the aid of a stainless steel measuring gauge (machine fabricated, accurate to 1 mm) inserted in the defect. For accurate comparative measurements, an xray film holder was modified for each patient so that it could be stabilized in position, or be removed and re placed in the same position. This was modified by the use of self-curing acrylic material placed on the biting rim of the holder where imprint of the occlusal surface of the teeth was made. 2. For gingival evaluation, gingival index (GI) scoring devised by Löe and Silness was used. However, this system was modified by scoring only the buccal and lingual gingivae in a given area. The gingivae were given a score of 0 to 3 according to the severity of inflamma tion. The values of the buccal and lingual scores were added and divided by 2 giving the G I mean for one particular implant site. This scoring was done pre- and postoperatively. 3. Blood chemistries (SMA-12) were also conducted for each patient before and at time of postoperative evaluation. This was treated statistically with Student's t test for any possible significant change. Surgery was performed under local anesthesia using 2% Xylocaine mixed with epinephrine (1:100,000).§ W i t h a sulcular incision around the involved tooth, followed by a releasing modified vertical incision at some distance from the implant site, a full thickness mucoperiosteal flap was reflected to expose the bony defect (Fig. 1). For easy reflection a similar vertical incision was made also on the lingual side. In one case, the incision was made continuing through the interdental papilla. Hence, the incision was directed at the implant site. To permit total closure following placement of the implant, an attempt was made to obtain adequate papillary tissue during this incisional procedure. N o osseous recontouring was at tempted, but intramarrow penetration was performed in the defect to improve communication with the marow spaces. A thorough root planing with hand instruments
by
E D M U N D O B . N E R Y , D.M.D.† K E N N E T H L . L Y N C H , PH.D.‡ BIOCERAMIC MATERIALS have been used successfully in the repair or reconstruction of different forms of osseous defects in "normal" healthy animals. These defects were either surgically created or induced. Previous ex periments on periodontal osseous defects in animals have shown that tricalcium phosphate ceramic was well tol erated by the tissue. Bone grew into the pores and repair of the periodontium was clearly demonstrated. How ever, one very important question arises: that is, will this ceramic react the same in naturally occurring osseous defects, and allow bone and soft tissue ingrowth to occur in its pores and create a strong biomechanical attachment with the periodontium? T o our knowledge, this has not been demonstrated in clinical conditions. The purpose of this study therefore was to initiate this type of inves tigation. Initially an attempt was made to investigate the effects of porous tricalcium phosphate ceramic in the repair of naturally occurring periodontal osseous defects on a clinical level involving the assessment of the gingival tissues at the implant site, the change in the pocket depth measurement and the blood chemistries.
10
1-8
5, 6
11
MATERIALS A N D METHODS
Since this was a pilot study, only six male adult patients were selected on a voluntary basis. The criteria for selection were: (1) The patient should have no evi dence of endocrine disorders and/or blood dyscrasias; (2) the patient should be free of mycotic, bacterial or viral infection; and (3) the patient should present clini cally and radiographically localized two or three wall infrabony defects as classified by Goldman and Cohen, found either on the mesial or distal aspect of a tooth. In this report, in four out of six cases, the defect was found on the distal edentulous aspect of the mandibular second 9
* Supported by the Medical Research Service of the Veterans Administration. † Chief, Dental Research Section, Dental Service, Veterans Admin istration Center, Wood (Milwaukee), Wisconsin and Assistant Clinical Professor in Periodontics, Marquette University School of Dentistry, Milwaukee, Wisconsin. ‡ Research Investigator, Veterans Administration Center, Wood (Milwaukee), Wisconsin and Head Orthopedic Research Laboratory and Lecturer, Orthopedic Surgery, Department of Orthopedic Surgery, The Medical College of Wisconsin, Milwaukee.
§ Astra Pharmaceutical Products, Inc., Worchester, Mass 01606.
523
524
J. Periodontol. October, 1978
Nery, Lynch
F I G U R E 1 A . Drawing illustration showing a vertical releasing incision made at some distance from the defect to obtain adequate soft tissue coverage. B . Viewing occlusally, a similar incision was made on the lingual.
and removal of "chronic granulation tissue" found in the defect was also instituted. This was followed by irrigation with normal saline solution. The prepared ceramic, with pore size of 400 to 500 micrometers and 50% pore volume, was then crushed to smaller pieces (Fig. 2) and lightly packed into the defect with an amalgam plugger. Care was taken not to overfill the defect. Bleeding was induced in order to cover the ceramic material with a blood clot. The flap was returned to the original position, being sure that the ceramic was completely covered. It was sutured with 4-0 silk interrupted sutures. A perio dontal dressing* was also used to protect the flap from possible displacement. Postoperatively, the patients were given oral penicillin (250 mg), one tablet three times daily for 7 days, and were maintained on a soft diet for 3 days. The sutures and dressing were removed 2 weeks postoperatively. N o probing was done for a period of 2 months, but these patients were seen for a checkup and reinforcement of oral hygiene every 2 weeks. Two patients, however, did not make these visits. Since difficulty was encountered in recalling these patients for a specific time interval, a selected postoper ative evaluation time was simply assigned to one patient; that is, only one patient was designated for 2 months postoperative evaluation time, the other for 4 months etc. The postoperative evaluation time ranges from 2 to 16 months. RESULTS
Postoperative healing was uneventful except for one patient whose ceramic implant exfoliated after a period of 3 weeks, which was apparently due to inadequate soft tissue coverage during wound closure. Because complete coverage of the implant was not obtained, the tissue became vulnerable to infection. This patient was there fore eliminated from the study. * Coe Pak, Coe Laboratories, Inc., Chicago, IL 60658.
F I G U R E 2 A . Porous tricalcium phosphate ceramic crushed into smaller pieces ready for implantation. B . This is compared to the original pellet form.
Gingival Index The gingival index, as summarized in Table 1, shows that the gingival tissue healed within a period of 2 months with no evidence of adverse inflammatory re sponse. It appears that this condition was maintained throughout the experimental period, except for one pa tient who demonstrated slight inflammation of the gin givae at the implant site when examined 12 months postoperatively. This was due to poor oral hygiene, but reinforcement of proper home care instructions reversed the condition. The inflammation observed following sur gery was the result of surgical trauma which subsided in approximately 3 to 4 weeks. Pocket Depth Radiographically, Table 1 shows that there was a significant coronal increase in bone height when mea sured from the base of the infrabony defect to the base
Volume 49 Number 10
Bioceramic in Periodontal Osseous Defects 525 TABLE 1. Pre- and Postoperative Gingival Index (GI) and Pocket Depth (PD) for Five Patients B
A*
D
C
E
Mean ± SD
Pre
2 Months
Pre
4 Months
Pre
6 Months
Pre
12 Months
Pre
16 Months
Pre
Post
0 6
0 3
0 11
0 9
0 14
0 4
1 11
1 5
0 12
0 7
0.20 ± 0.44 10.80 ± 2.94
0.20 ± 0.44 5.60 ± 2.40†
GI (0-3) PD (mm)
* Patients, † x gain = 5.20 mm.
F I G U R E 3 A . Preoperative radiograph showing measuring gauge inserted in osseous defect distal to the mandibular 2nd molar. B . Sixteen months postoperatively the defect (arrow) appears to be well filled to the alveolar crest with presumably new bone and/ or ceramic material, as illustrated with the measuring gauge. o f the a m a l g a m m a r k e r ( F i g . 3 A a n d B ) . T h e preopera t i v e m e a n v a l u e w a s 10.8 m m a n d p o s t o p e r a t i v e l y 5.6 m m , g i v i n g a m e a n g a i n o r fill o f 5 . 2 m m . I t s h o u l d b e noted that the measurement
FIGURE 4A. Three-walled infrabony defect on the mesial aspect of the right maxillary 1st molar (arrow) prior to ceramic implan tation. B . Two months postoperatively the ceramic (arrow) ap pears to blend with the surrounding osseous tissues.
change (P < 0.01). Based on the data obtained from the Technicon Instrument Corporation (Tarrytown, N Y ) ; S M A - 1 2 normal range, the postoperative mean value falls within this range.
s h o w n was made from the
base o f the defect to the a m a l g a m m a r k e r a n d n o t f r o m
DISCUSSION
the base o f t h e defect t o t h e a l v e o l a r crest, n o r t o t h e
Although we realize this study had a very limited number of subjects and limited criteria for evaluation, the results were promising. Clinically and hematologically we have shown that porous tricalcium phosphate ceramic was well tolerated by human tissue when used as an implant material for the repair of periodontal osseous defects. The G I score seems to indicate that there was no inflammatory response during the experimental period except for the immediate postsurgical trauma. Since no histological evaluation was made in this study, inflammatory cell infiltrate could not be accounted for at this time. For pocket depth measurement, an increase i n bone height was evident radiographically when measured from the base of the pocket to the amalgam marker. However, as yet it has not been determined whether this
gingival margin. I n e x a m i n i n g the radiographs, w e have noted also that the c e r a m i c m a t e r i a l seems to b l e n d w i t h the s u r r o u n d i n g bone, i n d i c a t i n g that the radiographic density is p r o b a b l y the same i n b o t h (Figs. 4 A a n d 4 B ) . A t the interface between the root surface a n dthe ceramic, the p e r i o d o n t a l l i g a m e n t space w a s difficult to delineate, p r o b a b l y sug gesting that there w a s inadequate space f o r d e v e l o p m e n t o f the entire w i d t h o f the ligament. H o w e v e r , the possi b i l i t y o f n e w soft t i s s u e a t t a c h m e n t
i n this area
cannot
be r u l e d out. Blood
Chemistries
A s illustrated i n T a b l e 2, the p r e - a n d postoperative S M A - 1 2 b l o o d chemistry study showed n o significant
526
J. Periodontol. October, 1978
Nery, Lynch TABLE 2.
Pre- and Postoperative Blood Chemistry Values for Five Patients
Patients (Male Adults) A
Blood test (SMA-12) Pre
2 Mon
Pre
T.P. (gm%) Alb (gm%)
6.90 4.60
8.00 5.50
7.50 5.20
C A (mg%) Inor Phos (mg%) Chol (mg%) Glu (mg%) B U N (mg%) Uric Acid (mg%) Creat (mg%) Tot Bili (mg%) Alk Phos (mU/ml) SGOT (mU/ ml)
8.60 3.60
10.00 3.60
9.70 3.40
2.95 80 13 7.60
3.15 90 12 6.80
2.15 80 13 5.00
1.10 0.40
1.30 0.70
1.20 1.20
D
C
B
M e a n ± S D ( l SD)
Pre
6 Mon
Pre
12 Mon
7.50 5.70
7.60 5.50
7.50 6.00
7.20 5.10
7.20 4.80
7.10 4.80
9.50 2.70
10.30 3.60
10.50 3.40
9.70 2.80
9.80 2.60
9.50 2.80
1.40 1.80 100 90 10 11 5.80 5.10
1.50 90 13 5.80
2.40 85 14 7.50
2.15 95 20 7.60
1.30 0.90
1.05 0.90
1.10 0.70
1.10 0.50
4 Mon
1.00 0.70
50
50
50
55
60
20.00
20.50
20.00
20.00 25.00
t*
E
Pre
Normal Range†
Pre
Post
7.00 4.80
7.25 ± 0.28 5.04 ± 0.35
7.44 ± 0.38 5.36 ± 0.54
0.78 1.52
6.00-8.50 3.50-5.20
8.90 3.40
9.56 ± 0.62 3.24 ± 0 . 4 1
9.74 ± 0.59 3.14 ± 0 . 4 6
0.54 0.48
8.50-10.50 2.50-4.50
2.10 ± 0 . 6 3 98 ± 12.36 12.60 ± 4.56 6.38 ± 0.96
0.86 2.71 0.34 0.44
1.50-3.10 55-135 10-26 4.00-9.00
1.11 ± 0 . 1 2 0.64 ± 0 . 1 9
0.62 1.18
0.70-1.40 0.20-1.20
0.34
30-115
0.16
7.00-40.00
16 Mon
2.05 1.90 2.19 ± 0 . 5 6 89 ± 12.44 110 115 8 13.40 ± 1.81 16 6.40 6,60 6.46 ± 1.11 1.10 0.90
Value
1.10 0.40
1.16 ± 0 . 8 9 0.82 ± 0.29
45
70
65
60
70
57 ± 8.36
25.00
15.00
35.00
45.00
25.00 25.00 ± 11.72
58 ± 10.36 25.10 ± 6 . 0 2
*t = 4.60; P< 0.01. † Normal range taken from Technicon Instruments Corp., Tarrytown, N Y 10591.
increase was made up of bone and/or ceramic. In as sessing the repaired pockets, it was not possible to deter mine whether we have a new soft tissue attachment between the root surface and the periodontium. Only histologic studies, which are being initiated i n our labo ratory at this time, could furnish the answer to these problems. Hematologically, it is quite clear that the blood chem istries ( S M A - 1 2 ) were not affected by the ceramic im plant, indicating that the material causes no ill effects to the vital organs (especially liver and kidney), nor was there an alteration i n the metabolism of calcium and phosphorous, or the enzyme systems. O f course, other factors may be involved which are beyond the scope of this investigation. Throughout the experimental period it appears that porous tricalcium phosphate ceramic is nontoxic to hu man tissue and could be used as a potential alternative to bone grafting. Finally, it should be noted that all of the patients remained free of any clinical complaints following subsidence of the immediate postsurgical dis comfort. Future work is directed to histological evalua tion of the implant and implant site correlated with clinical findings. SUMMARY
In six patients, porous tricalcium phosphate ceramic (400 to 500 micrometer pore diameter and 50% pore volume) was used to repair naturally occurring perio dontal osseous defects. These patients were evaluated clinically, radiographically and hematologically. The clinical evaluation indicated that there was no adverse
inflammatory response at the implant site except the anticipated immediate postsurgical trauma. Radiograph ically, there was a significant increase i n bone height with a mean gain of 5.2 mm. Whether or not this gain consisted of bone and/or ceramic is yet to be conclusively determined. The S M A - 1 2 blood chemistry study re vealed that no significant change occurred pre- or post operatively (P< 0.01). Although the number of patients i n our study was limited, the results are very promising. The ceramic is nontoxic to human tissue and repair of the periodontium is most likely obtainable, the desired objective being the restoration of the natural state of the periodontium. ACKNOWLEDGMENTS
The authors wish to thank Dr. Walter Hirthe, Marquette University College of Engineering, for supplying us with the ceramic material; Dr. Vernon D. Foshager for his comments and criticism; Carole Russell-Hilmer for preparing the drawing illustration; and Catherine A. Walther for her editorial assist ance. REFERENCES
1. Bhaskar, S. N., Brody, J. M., Getter, L., Gromer, M . F., and Driskell, T. D.: Biodegradable ceramic implants in bone. Oral Surg 32: 336, 1971. 2. Tennery, V. J., and Driskell, T. D.: SEM studies of boneceramic interfaces in calcium phosphate resorbable ceramic (abstr.). Ceramic Bulletin, Society Symposium on Biomaterial, p. 430, 1973. 3. Driskell, T. D., Hassler, C. R., Tennery, V. M., McCoy, L. R., and Clark, W. J.: Resorbable ceramics: A potential alternative to bone grafting (abstr.). J Dent Res 52: 123, 1973. 4. Topazian, R. G., Hammer, W. B., Talbert, C. O., and Hulbert, S. F.: The use of ceramics in augmentation and
Volume 49 Number 10
Bioceramic in Periodontal Osseous Defects 527
replacement of portions of the mandible. J Biomed Mater Res 6:311, 1972. 5. Levin, M . P., Getter, L., Cutright, D. E., and Bhaskar, S. N.: Biodegradable ceramic in periodontal defects. Oral Surg 38: 344, 1974. 6. Nery, E. B., Lynch, K. L., Hirthe, W. M., and Mueller, K. H.: Bioceramic implants in surgically produced infrabony defects. J Periodontol 46: 328, 1975. 7. Pedersen, K . N.: Rebuilding of deficient edentulous al veolar ridge with porous ceramic implants. Int J Oral Surg 5: 133, 1976.
8. Lynch, K . L., Mueller, K . H., Hubbard, W. G., and Hirthe, W. M . : Porous physiological calcium phosphates in orthopedic biomaterials. Clin Orthop (in press). 9. Goldman, H . M., and Cohen, D. W.: The infrabony pocket: Classification and treatment. J Periodontol 29: 272, 1958. 10. Updegrave, W. J.: Paralleling extension—cone tech nique in intraoral radiography. Oral Surg 4: 1250, 1951. 11. Löe, H., and Silness, J.: Periodontal disease in preg nancy: Prevalence and severity. Acta Odontol Scand 21: 533, 1963.
Announcements P O S T G R A D U A T E D E N T A L P R O G R A M , A L B E R T EINSTEIN C O L L E G E O F MEDICINE The following courses are available during the academic year, 1978-1979 OCCLUSION DPD 36 (Coronal Reshaping: A Practical Treatment for Occlusal Problems of the Adult), IRA FRANKLIN ROSS, D.D.S., Wednesdays, October 25, and November 1, 1978, $160. PERIODONTIC REVIEW COURSE DPD 43,
M A R V I N N. O K U N , D.D.S.,
IRVING Y U D K O F F , D.D.S., BERTRAM S. BILDNER, D.D.S., and E D
P O S T G R A D U A T E C O U R S E IN H E A D A N D NECK ANATOMY A four-day course entitled "The Alton D. Brashear Postgraduate Course in Head and Neck Anatomy" will be held at the Medical College of Virginia, Department of Anatomy, January 15-18, 1979. Fresh specimens (unpreserved) whenever possible are used in the dissections and individual surgical approaches are welcomed. Lectures and demonstrations will augment the laboratory work. The course is approved for 40 elective hours by the American Academy of General Practice and Academy of General Dentistry.
MUND D. D'ONOFRIO, D.M.D., Wednesday, November 8, 1978, $70. PERIODONTICS
DPD 66 (A 20 Session Periodontics Participation
Course) M A R V I N N. O K U N , D.D.S., IRVING Y U D K O F F , D.D.S., BER
Further information may be obtained from Dr. Hugo R. Seibel, Department of Anatomy, Medical College of Virginia, Richmond, Virginia 23298.
TRAM S. BILDNER, D.D.S., E D M U N D D. D ' O N O F R I O , D.M.D., JOSEPH F. Puccio, D.D.S., K A L M E N
D. EINBINDER, D.D.S., D A N I E L M .
NACHMANOFF, D.D.S., and DAVID L. RAUCHER, D.D.S., 20 Wednes days, commencing January 3, 1979 through May 16, 1979, $2,100 (including manuals). TEMPOROMANDIBULAR JOINT DISORDERS DPD 86, J O H N R. VAROSCAK,
D.D.S., Friday, March 23, 1979, $70. PERIODONTICS DPD 94, NINETEENTH ANNIVERSARY A L U M N I L E C T U R E , T H E D R . Z A C H A R Y D E M B O M E M O R I A L L E C T U R E (Methods of Treat
ment of Periodontal Pockets), SIGURD P. RAMFJORD, D.D.S., Ph.D., Wednesday, April 25, 1979, $70. RECONSTRUCTIVE
PERIODONTAL
SURGERY
DPD
102,
MORRIS
P.
R U B E N , D.D.S., Wednesday, May 16, 1979, $70. POSTGRADUATE EXTENSION PROGRAM (off
campus courses): Faculty
members of the Postgraduate Dental Program, who are specialists in their fields, are available for short, intensive courses that can be given in various cities if a sufficient number of practitioners evince interest. If clinical facilities are available, these courses can be a combination of lectures and demonstrations. For further information and application, write to: Dr. Irving Yud koff, Director, Postgraduate Dental Program, Albert Einstein College of Medicine, 1165 Morris Park Avenue, Bronx, New York 10461.
I N T E R N A T I O N A L SYMPOSIUM O N R E C E N T A D V A N C E S IN CLINICAL PERIODONTOLOGY Tel-Aviv University School of Dental Medicine and Toronto A l umni Chapter, Alpha Omega Fraternity announce the International Symposium on Recent Advances in Clinical Periodontology, October 25 and 26, 1978, Tel-Aviv University Dental School, Israel. Main subjects will be presented by Prof. JAN E G E L B E R G , Depart ment of Periodontology, School of Dentistry, Malmo, Sweden; Prof. M A X A. LISTGARTEN, Department of Periodontics, Center for Oral Health Research and School of Dental Medicine, University of Penn sylvania. Some titles: Efficiency of Plaque Control Programs for Adult Patients, Subgingival Scaling vs. Periodontal Surgery, Reattachment Potentials of the Periodontal Tissues, Maintenance Therapy and LongTerm Prognosis after Periodontal Treatment, Development and Struc ture of Periodontal Tissues, Development and Structure of the Perio dontal Flora, Current Views on the Histopathology of the Gingival Lesion, The Gingival Sulcus and Pocket: Histological and Clinical Considerations. For further information contact: The Secretary, School of Dental Medicine, Tel-Aviv University, Ramat-Aviv, Tel-Aviv, Israel, or Dr. Hart Levin, 2006 Bathurst St., Toronto, Ontario, M5P 3L1, Canada, (416) 781-2006.
