Clin Oral Invest DOI 10.1007/s00784-015-1448-x

ORIGINAL ARTICLE

Pain after single-visit root canal treatment with two single-file systems based on different kinematics—a prospective randomized multicenter clinical study Prasanna Neelakantan & Subash Sharma

Received: 18 October 2014 / Accepted: 3 March 2015 # Springer-Verlag Berlin Heidelberg 2015

Abstract Objectives The aim of this study is to evaluate the posttreatment pain after instrumentation of root canals with a singlefile reciprocating (RECIPROC, VDW, Germany) or rotary (One Shape, MicroMega, France) file system. Materials and methods Six hundred forty patients were assessed for eligibility, and 624 patients were included in this study. The teeth were randomly allocated to one of the instrumentation protocols. The teeth underwent routine root canal treatment after which patients were discharged with a questionnaire to gather data about the incidence (yes/no), nature (mild, moderate, or severe), and duration of pain (days). The data were analyzed using statistical analyses (preoperative pain scores by Mann-Whitney U test, incidence and intensity of pain by chi-squared test, intake of analgesics, and duration of pain by Student’s t test) with P=0.05. Results Pain analysis was performed for 605 patients (311 males and 294 females) as 5 patients were excluded due to sealer extrusion and 14 were lost to follow-up. The mean age of the patients was 31±2 years. There was significant difference in the incidence of postoperative pain (P30°, resorption, radiographic evidence of calcification, or open apices) Two or more adjacent teeth requiring root canal therapy More than two mandibular molars requiring root canal therapy Presence of sinus tracts Absence of occlusal contacts Medically compromised patients

The clinical and radiographic data of the patients were assessed by a team of three endodontists who were blinded to the experimental protocols. A total of 16 patients were excluded because they did not meet the criteria for inclusion. Following administration of an inferior alveolar nerve block and a buccal infiltration with one carpule of local anesthetic (lignocaine hydrochloride with 1:80,000 epinephrine; Lignospan special, Septodont), the affected tooth was isolated with rubber dam. No patient required more than one carpule of local anesthetic. Access cavities were prepared with the Cavity Access Kit (Dentsply Maillefer, Ballaigues, Switzerland). On exposure of the pulp chamber, if hemorrhage was not noticed, patients were excluded from the study. Initial scouting of the canals was done using a size 10 C Pilot file (VDW, Munich, Germany), using EDTA gel (Glyde, Dentsply Maillefer, Ballaigues, Switzerland) as the lubricant. The tooth

Clin Oral Invest

was then allotted to one of the instrumentation techniques based on a sealed envelope method by a dental assistant who was blinded to the experimental protocols. The other tooth to be treated was automatically enrolled under the second instrumentation system. Both teeth requiring root canal treatment were treated the same day with a minimum time interval of 4 h. Group 1 (n=624) Root canal preparation was done with the RECIPROC system (VDW) with strict adherence to the manufacturer’s instructions. After coronal preflaring with a R25 instrument with 3 % sodium hypochlorite (Parcan, Septodont, Saint-Maur-des-fosses Cedex, France) as the irrigant, working length was determined and a glide path was created. The R25 instrument was used to complete the root canal shaping if a size 15 file fit passively into the canal. For larger canals where size 20 or 30 fit passively to length, the R40 or R50 files were used respectively. Group 2 (n=624) Root canal preparation was done with the One Shape system (Micro-Mega) following manufacturer’s instructions. Coronal preflaring was done with Endoflare files, after which glide path was created. Following this, the One Shape file was used to shape the root canals. Working length was determined using an electronic apical foramen locator (EAL) (Root ZX, J.Morita, Kyoto, Japan) with size 12.5 C Pilot file. Radiographic determination of working length was also done, but in the case of disagreement between the two values, the EAL reading was selected. Precurved size 12.5 and 15 C Pilot files were used to create a glide path in both the groups, using EDTA gel as the lubricant. For both the systems, the VDW Gold Reciproc motor (VDW) was used with the appropriate settings as recommended by the manufacturer. While the RECIPROC was operated in the BRECIPROC ALL^ mode, One Shape was used at a speed of 400 rpm and 2.5 N torque. Apical patency was maintained throughout the shaping process using a size 10 K file; 3 % NaOCl was used as the irrigant during the preparation, delivered using a 30G Max-iprobe needle (Dentsply Rinn, IL, USA). The irrigant was allowed to remain in the canal for 5 min after which it was flushed out with sterile saline and irrigated with 2 mL of 17 % ethylenediaminetetraacetic acid solution, which was allowed to remain in the canal for 2 min. Ultrasonic activation of 1 mL of 3 % NaOCl was performed using ultrasonic files (IrriSafe, Satelec Acteon, Merignac, France) in an ultrasonic generator (EMS 600 ultrasonic unit) for 30 s. The canals were refilled with fresh 1 mL of 3 % NaOCl, and ultrasonic activation was resumed for 30 additional seconds. The EDTA was flushed out with saline and canals were dried with paper points. The roots canals were obturated using gutta-percha points and a mineral trioxide aggregate sealer (MTA Plus, compounded by Prevest Denpro, Jammu, India, for Avalon Biomed Inc. Bradenton,

FL, USA) by warm vertical condensation method (E&Q Plus, Meta Biomed, Chungbuk, Korea). Following radiographic confirmation of the obturation, coronal seal was provided with a high-strength glass ionomer cement (Amalgomer, AHL, Kent, UK). If any evidence of extrusion of root filling material was noticed radiographically, patients were excluded from the study (n=5). No occlusal reduction was performed. All patients who met the final inclusion criteria were given a pain chart to be completed to record the incidence of pain (yes/no), level of posttreatment pain (Table 1), and duration of pain (days). They were asked to submit the forms after 1 week. Patients were prescribed an optional medication of ibuprofen (400 mg, 8–12 h). Patients were asked to record the information if they took the medication. If the patient was unable to locate the source of pain, they were excluded from the study. A modified visual analogue scale (VAS) was employed for assessment and statistical comparison of pain scores: score 0, absolutely nothing; scores 1–3 (mild), very weak discomfort or mild pain but requiring no intervention and not influencing ordinary activities of daily life; does not require analgesics; scores 4–6 (moderate), moderate pain which is distracting for the patient and occasionally negatively influences the patient from performing his normal daily activities; the pain is relieved with analgesics; scores 7–10 (severe), this score range covered very severe and extremely severe/

Table 1 Incidence (yes/no), intensity (mild, moderate, severe), and duration (days) of posttreatment pain after instrumentation with two single-file systems (Reciproc and One Shape) (n=605) Incidence

No pain Yes

Intensity

Mild

Moderate

Severe

Duration

1 2 3 4 5 1 2 3 7 1 2 3 7

Distribution (n) Group 1 (Reciproc)

Group 2 (One Shape)

507 56 12 1 1 – 18 1 – – 1 2 5 1

462 25 3 2 1 1 29 19 2 3 39 14 3 2

There was significant difference in the incidence of postoperative pain between the two groups (chi-squared test; P

Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study.

The aim of this study is to evaluate the posttreatment pain after instrumentation of root canals with a single-file reciprocating (RECIPROC, VDW, Germ...
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