J Clin Periodontol 2014; 41: 481–488 doi: 10.1111/jcpe.12239

Influence of intra-pocket anesthesia gel on treatment outcome in periodontal patients: a randomized controlled trial

Sonja H. M. Derman1, Claudia E. Lowden1, Martin Hellmich2 and Michael J. Noack1 1

Center of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Cologne, Germany; 2 Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany

Derman SHM, Lowden CE, Hellmich M, Noack MJ. Influence of intra-pocket anesthesia gel on treatment outcome in periodontal patients: a randomized controlled trial. J Clin Periodontol 2014; 41: 481–488. doi: 10.1111/jcpe.12239.

Abstract Aim: Compare the treatment outcome after scaling and root-planing using local anesthesia gel or injected local anesthesia. Material and method: Thirty-eight patients with periodontitis and good general health were included in a randomized, single-blind, split-mouth clinical trial. Probing depths and clinical attachment levels were recorded at baseline and 6 weeks after treatment. Performed treatment procedures were scaling and root planing using two types of local anesthesia for separate treatment appointments. Anesthetics used were intra-pocket lidocaine and prilocaine gel (2.5% each) and injected articaine (1:100,000 adrenaline). Type of anesthesia for first appointment was randomized and switched for second appointment. Patients0 pain perception and anesthesia acceptance were recorded on questionnaires. Results: No influence of applied type of anesthesia could be detected for change of probing pocket depths and clinical attachment level (p > 0.05). These findings are valid even for deeper pockets. Gel-group had significant higher intra-operative pain perception. In retrospect 69% of patients favored gel. Conclusion: Treatment outcome is not compromised by use of anesthesia gel in comparison to injected anesthesia. The same beneficial results for probing pocket depths and clinical attachment gain could be detected. The majority of patients prefer local anesthesia gel despite a slightly greater procedural discomfort.

Pain control is considered to be an important outcome measure for successful periodontal therapy (Heft et al. 1991, Kumar & Leblebicioglu Conflict of interest and source of funding statement The authors declare that there are no conflicts of interest in this study. No external funding, apart from the support of the authors0 institution, was available for this study.

2007), because sustained periodontal maintenance depends on pain perception. Injected local anesthetics have been used to secure anesthesia for scaling and root planing (SRP) and continue to be the anesthetic of choice for profound pain control (Kumar & Leblebicioglu 2007). However, the use of injected anesthesia is associated with adverse effects and is in itself a cause for discomfort and fear (Milgrom et al. 1997, Karadottir et al.

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Key words: anesthetics; articaine; lidocaine; periodontitis; prilocaine; scaling and root planing; treatment outcome Accepted for publication 29 January 2014

2002). A somewhat less profound anesthesia during SRP with intrapocket anesthesia gel is clearly preferred by patients. Reasons are lower incidence of post-procedure problems and the absence of discomfort caused by injection (van Steenberghe et al. 2004a, Derman et al. 2013). As an alternative to injection, topical and sulcular anesthesia options have been developed and tested to avoid patients0 discomfort caused by injection. A transmucosal

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patch containing 10% or 20% lidocaine produced a sufficient anesthesia for non-surgical periodontal therapy (Perry et al. 2005). Disadvantages in costs and adherence of patch in posterior regions were reasons for failure of this product in daily practice. An intra-pocket anesthesia gel containing lidocaine (2.5%) and prilocaine (2.5%) in a thermosetting agent showed to be a suitable, safe and practicable alternative to control intra-operative pain during mechanical SRP in various treatment modalities: hand and/or power-driven instrumentation, laser debridement (Friskopp & Huledal 2001, Friskopp et al. 2001, Jeffcoat et al. 2001, Donaldson et al. 2003, Magnusson et al. 2003, van Steenberghe et al. 2004a, Badran et al. 2012, Derman et al. 2013, Mayor-Subirana et al. 2013). Pain perception during debridement is depending on the applied treatment modality, in which power-driven instrumentation produces less procedural pain than hand instrumentation (Braun et al. 2003, Kocher et al. 2005). This intra-pocket anesthesia gel has a lower analgesic efficacy than injected anesthesia (van Steenberghe et al. 2004a). As a topical anesthetic, the gel is only able to reduce the soft tissue pain perception and will have no effect on pulpal pain or dentin hypersensitivity. It may be presumed that more intraoperative pain leads the dentist to a lower process quality in non-surgical periodontal therapy. No data are available focusing on treatment outcome after SRP when comparing injection and gel anesthesia. The purpose of this randomized, single-blind, split-mouth study was to determine treatment outcome after SRP with intra-pocket anesthesia gel in comparison to injected anesthesia considered as gold standard. Treatment outcome was measured by change of probing pocket depths (PPD) and change of clinical attachment level (CAL). Secondary endpoints were the evaluation of pain perception during SRP and patients’ preferred choice of anesthesia. Material and Methods Study design

The present study was designed as a split-mouth, randomized, blinded

and clinical trial of 2 months duration. The contralateral cross-over split-mouth design was chosen for three reasons: (1) Split-mouth trials are indicated when no or equal carry–across effects are present (Hujoel & DeRouen 1992). If an intraindividual carry-over effect from treated to untreated pockets exists, it is distributed symmetrically over both groups by the cross-over design. (2) When disease characteristics are symmetrically distributed over the within-patient experimental units, the split mouth design can provide moderate to large gains in efficacy compared to full-mouthdesign (Hujoel & Loesche 1990). Between-group differences were excluded at baseline for PPD and CAL by a paired t-test with a 95% confidence-interval covering the zero point. (3) In a split-mouth design, sample size can be reduced to 25%, which generates an ethical and financial benefit. The study design was approved by the University of Cologne local ethic review board (08-034) and was performed in agreement with the Helsinki Declaration. All participants were individually informed about the nature of the proposed treatment, and informed consent forms were signed. The study was performed at the Center of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne. The aim of the study was to compare treatment outcome after SRP as influenced by use of anesthesia gel with 2.5% lidocaine and 2.5% prilocaine (gel group) or injected articaine with epinephrine 1:100,000 (injection group). Additionally, pain levels experienced during SRP and patients0 preference of local anesthesia were evaluated. Population screening

Thirty-eight patients with untreated periodontitis were screened for eligibility and recruited after completion of a periodontal prophylaxis program (including oral hygiene instructions and repeated supragingival professional tooth cleaning). Patients who were invited to participate met the following inclusion criteria: (1) at least four sites with probing depths of 4 mm or more per dental quadrant; (2) at least 18 years

old. Exclusion criteria were as follows: (1) allergy to lidocaine, prilocaine or local anesthesia of amid type; (2) consumption of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) in the 3 months prior to treatment; (3) gross caries; (4) periodontal abscesses; (5) denture related soreness; (6) pregnant or lactating patients. Randomization and allocation concealment

A randomization into two groups with 19 patients each was performed by senior investigator (M. J. N.). The randomization list was generated by “rolling-the-dice”, even numbers for gel, odd numbers for injection. After completion of one group with 19 patients, the remaining were assigned to the other group. This is, however, equivalent to a block randomization using only one single block. The type of anesthesia for the first treatment appointment was randomly assigned and switched for the second. The allocation concealment was secured by having a person not involved in the study performing the randomization. Patients0 anesthesia was performed by nonblinded investigator (S. N.). The blinded examiner (S. H. M. D.) performed periodontal examinations, treatment procedures and safety protocol evaluation. Thus, anesthesia type was not revealed to the blinded examiner. Baseline examination

At baseline every patient underwent a periodontal examination including PPD and CAL recorded by Florida Probeâ (Gainsville, FL, USA) at six sites per tooth followed by a soft tissue examination. Patients were individually instructed by the use of a 0–100 visual analogue scale (VAS) and a five step verbal rating scale (VRS) to record experienced pain levels. Treatment

During the first treatment appointment the dental quadrants on the right received either anesthesia gel

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Anesthesia gel and treatment outcome with 2.5% lidocaine and 2.5% prilocaine (gel group) or infiltration by injected articaine with epinephrine 1:100,000 (injection group) as assigned by the randomization list. The type of anesthesia was switched for the second appointment treating dental quadrants on the left. No topical cream was applied before injection. If no sufficient pain reduction during SRP had been reached, patients were free to opt for a “rescue anesthesia” (additional application of infiltration anesthesia). Appointments were scheduled weekly. SRP was performed using an ultrasonic scaler (Cavitronâ with Slimline inserts, Dentsply, York, PA, USA) to remove coarse concrements and disrupt the subgingival biofilm followed by Gracey curettes (Hu-Friedy, Chicago, IL, USA) to remove the endotoxin-burdened root surface and perform the root planing. Treatment endpoint was defined by smooth and accretions free root surfaces using a periodontal explorer (EXD 11/12; Hu-Friedy). Treatment times for hand and power-driven instrumentation were not recorded. After each SRP treatment, the patients filled in a pain questionnaire to assess VAS and VRS levels. Re-assessment examination

Six weeks after the second treatment appointment the reevaluation of PPD and CAL was recorded again using a Florida Probeâ. Subsequently, participants filled in the patients’ choice questionnaire. Clinical measurements

The following clinical parameters were recorded during the study: at baseline and 6 weeks after treatment CAL and PPD were measured at six sites per tooth using a standardized, computerized periodontal probe (Florida Probeâ, FP32 Software, Version 4.4.19, Florida Probe Corporation, Gainsville, FL, USA). Intra-oral soft tissue examination was performed by the blinded examiner at baseline and after each treatment appointment (safety protocol). After the treatment appointments patients filled in questionnaires to record pain levels experienced by using a 0–100 VAS and a five step VRS. At re-assessment examination

appointment, patients’ preference of anesthesia applied was assessed on a self-filled questionnaire. Sample size calculation

In order to demonstrate non-inferiority regarding change in PPD (baseline to recall), 33 patients are required to give the paired t-test 80% power (one-sided type I error a = 0.025, non-inferiority bound d = 0.5 mm, standard deviation r = 1 mm). To account for about 15% drop-out, 38 patients were included and randomized. Statistical analysis

Quantitative data were summarized by mean and standard deviations. Outcome variables (e.g. CAD, PPD) were compared by treatment (gel versus injection) using the paired ttest adjusted for baseline imbalance (i.e. intercept in linear regression). Substantial deviation from normality was excluded by Shapiro-Wilk statistics and, thus, parametric 95% confidence intervals were calculated to support interpretation. Pain perception and anesthesia choice (visual analogue scales) were compared by treatment using the Wilcoxon signed rank test. All analyses were done at patient level (unit of analysis) using SPSS Statistics software (IBM Corp., Armonk, NY, USA). p-Values lower or equal 0.05 were considered to indicate statistical significance. Results Demographics and treated teeth characteristics

Thirty-eight patients (19 female, 19 male) were randomized; 33 patients (16 female, 17 male) completed the study. Five patients were excluded because of rescue anesthesia during SRP. Figure 1 illustrates the study flowchart. The average age (SD) of patients was 56 (11) years with a range of 27–73 years. The patients had had no periodontal treatment prior to the study. In the “gel – injection” sequence, the mean number of treated teeth (SD, range) for the gel group was 11.4 (2.8, 5 to 15) and for the injection group 11.2 (2.9, 6 to 15). For the “injection – gel” sequence, the

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

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mean number of treated teeth (SD, range) for the gel group was 12.2 (2.6, 6 to 15) and for the injection group 12.4 (2.4, 5 to 15). Additional details for pre–treatment distributions are shown in Table 1. Betweengroup differences were excluded at baseline for PPD and CAL by paired t-test with a confidence-interval that covered the zero point, ensuring comparability of both groups. Safety protocol (including soft tissue examination) was performed by the blinded examiner after each treatment appointment. No evidence of adverse effects was detected in both anesthesia groups. No patient reported an adverse event, although five of them (13%) required rescue anesthesia. Treatment outcome

Percentage of pockets The percentage (SD) of PPD not less than 4 mm, similarly (p = 0.365) decreased from baseline to recall in the gel group by about 36.8% (11.8) and in the injection group by about 39.2% (12.3). Similar results were found for deeper pockets (not less than 6 mm) (p = 0.915). The percental reduction (SD) in the gel group was 7.6% (8.3) and in the injection group 8.3% (9.1). Details are presented in Table 2. Probing pocket depth Analysis of change of PPD overall showed no statistical difference (p = 0.121) between gel group and injection group (Table 3). The mean change per site (SD) in the gel group was 1.19 mm (0.37) compared to 1.28 mm (0.40) in the injection group. In moderate pockets (4– 5 mm) the mean change per site (SD) in the gel group was 1.73 mm (0.40) compared to 1.85 mm (0.44) in the injection group (p = 0.060). Even in severe pockets (≥6 mm) no difference in change of PPD per site could be detected (p = 0.928). Per protocol (PP) analysis was performed confirming robustness of the results obtained by intention to treat (ITT) analysis. Details are presented in Table 3. Clinical attachment level Analysis of change of CAL overall showed no statistical difference

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Visual analog scale Anesthesia gel use was associated with significantly higher intra-operative VAS pain scores (in mm) than was injected anesthesia (p = 0.000). This difference remained statistically significant according to patients’ gender, female (p = 0.014) and male (p = 0.007). Subdividing patients by treatment assignment and gender, female patients showed significantly (p = 0.000) more pain in the gel group (30.3, SD 24.5) than in the injection group (14.2, SD 19.1). No gender related differences were detected in the injection group (p = 0.186). VAS pain scores are demonstrated in Table 5. Intention to treat analysis (ITT) was performed confirming robustness of the results obtained by per protocol (PP) analysis. Verbal rating scale

Fig. 1. Flowchart for study patients.

(p = 0.996) between gel group and injection group (Table 4). The mean change per site (SD) in the gel group was 0.98 mm (0.41) compared to 1.00 mm (0.43) in the injection group. For moderate pockets at baseline (4–5 mm) the mean change per site (SD) in the gel group was 1.47 mm (0.46) compared to

1.52 mm (0.56) in the injection group (p = 0.778). Even in severe pockets at baseline (≥6 mm) no difference in change of CAL per site could be detected (p = 0.159). Per protocol (PP) analysis was performed confirming robustness of the results obtained by ITT analysis. Details are presented in Table 4.

Verbal rating scale pain scores confirm the results found by VAS pain scores. The five step VRS was divided as follows: (0) no pain, (1) mild pain, (2) moderate pain, (3) severe pain and (4) extreme pain. The gel group reported significantly (p = 0.000) more intra-operative pain than the injection group. However, no or merely mild pain was reported in 81.8% in the gel group and 94.0% in the injection group. (Detailed: gel group: no pain 12.1%, mild pain 69.7% versus injection group: no pain 66.7%, mild pain 27.3%) When comparing groups on a gender basis, female (p = 0.008) and male (p = 0.005) patients reported more pain in the gel group than in the injection group. When dividing patients by treatment

Table 1. Baseline characteristics of teeth by treatment Baseline characteristics Number of teeth

Sequence Gel – injection Injection – gel

Number of pockets ≥ 4 mm

Gel – injection Injection – gel

Number of pockets ≥ 6 mm

Gel – injection Injection – gel

Treatment Gel Injection Gel Injection Gel Injection Gel Injection Gel Injection Gel Injection

Quadrants 1, 2, 2, 1, 1, 2, 2, 1, 1, 2, 2, 1,

4 3 3 4 4 3 3 4 4 3 3 4

Number of patients 19 19 19 19 19 19 19 19 19 19 19 19

Mean  SD (range) 11.4 11.2 12.2 12.4 29.2 29.5 33.8 36.4 3.8 3.7 8.3 9.7

           

2.8 (5 to 15) 2.9 (6 to 15) 2.6 (6 to 15) 2.4 (5 to 15) 10.0 (13 to 45) 10.5 (15 to 57) 14.7 (13 to 59) 13.4 (11 to 62) 3.4 (0 to 11) 3.8 (0 to 15) 8.7 (0 to 24) 9.4 (1 to 36)

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Anesthesia gel and treatment outcome

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Table 2. Distribution of pocket depths (in%) by treatment assignment and time Percentage of pockets Pockets ≥ 4 mm

Sequence (n)

Treatment

Gel – injection (n = 19) Injection – gel (n = 19)

Quadrants

Gel Injection Gel Injection

1, 2, 2, 1,

4 3 3 4

Difference baseline/recall in% (SD) Pockets ≥ 6 mm

Gel – injection (n = 19) Injection – gel (n = 19)

Gel Injection Gel Injection

1, 2, 2, 1,

4 3 3 4

Difference baseline/recall in% (SD)

Baseline Mean  SD (range)

Recall Mean  SD (range)

42.9  10.1 (21 to 61) 44.5  11.0 (27 to 68) 45.9  16.1 (24 to 76) 48.8  15.4 (19 to 79) Gel Injection 5.5  4.5 (0 to 14) 5.6  5.4 (0 to 19) 11.2  11.6 (0 to 31) 13.1  12.5 (1 to 46) Gel Injection

6.5 5.2 8.8 8.8 36.8 39.2 0.7 1.0 0.9 1.0 7.6 8.3

           

8.0 (0 to 35) 10.1 (0 to 45) 11.7 (0 to 36) 11.7 (0 to 36) 11.8 12.3 1.9 (0 to 7) 3.4 (0 to 15) 2.0 (0 to 6) 2.5 (0 to 10) 8.3 9.1

Difference (CI) p-value*

0.6 (1.9 to 0.7) 0.365

0.0 (0.6 to 0.5) 0.915

*By paired t-test adjusted for baseline means. Table 3. Mean probing pocket depths (PPD) by treatment assignment and time Mean PPD

Sequence

Treatment (n)

Gel (n = 19) Injection (n = 19) Injection – gel Gel (n = 19) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

Pockets ≤ 3 mm

Gel (n = 19) Injection (n = 19) Injection – gel Gel (n = 19) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

Gel – injection

Gel (n = 19) Injection (n = 19) Gel (n = 19) Injection (n = 19)

1, 2, 2, 1,

Gel (n = 17) Injection (n = 16) Injection – gel Gel (n = 18) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

All

Pockets 4–5 mm

Gel – injection

Quadrants

Gel – injection

Injection – gel

4 3 3 4

4 3 3 4

4 3 3 4

Difference baseline/recall mm (SD) Pockets ≥ 6 mm

Gel – injection

4 3 3 4

Baseline Mean  SD (range) 3.3  0.3 3.4  0.3 3.5  0.6 3.6  0.6 Gel Injection 2.4  0.2 2.5  0.2 2.4  0.2 2.4  0.2 Gel Injection 4.2  0.1 4.2  0.1 4.3  0.1 4.4  0.1 Gel Injection 6.7  0.7 6.3  0.5 6.4  0.5 6.5  0.4 Gel Injection

(2.5 (2.8 (2.9 (2.6

(2.0 (2.1 (2.1 (2.1

(4.1 (4.0 (4.1 (4.1

(6.0 (6.0 (6.0 (6.0

to to to to

to to to to

to to to to

to to to to

4.0) 4.1) 4.5) 5.2)

2.8) 2.7) 2.6) 2.7)

4.5) 4.4) 4.5) 4.7)

8.4) 7.5) 7.3) 7.5)

Recall Mean  SD (range) 2.2 2.2 2.3 2.3 1.19 1.28 1.9 1.9 1.9 1.9 0.54 0.55 2.5 2.5 2.5 2.5 1.73 1.85 3.5 3.3 2.9 3.1 3.34 3.22

                       

0.4 (1.5 0.5 (1.6 0.4 (1.8 0.4 (1.6 0.37 0.40 0.3 (1.3 0.3 (1.2 0.2 (1.6 0.2 (1.4 0.25 0.31 0.5 (1.8 0.5 (2.0 0.3 (2.0 0.4 (1.7 0.40 0.44 1.5 (2.0 1.3 (2.0 0.9 (1.7 0.5 (2.0 1.12 0.92

to to to to

Difference (CI) p-value*

3.3) 3.7) 3.1) 3.4) 0.04 (0.08 to 0.01) 0.121

to to to to

2.3) 2.3) 2.3) 2.2) 0.00 (0.06 to 0.05) 0.892

to to to to

4.4) 4.4) 3.1) 3.1) 0.07 (0.14 to 0.00) 0.060

to to to to

8.4) 7.2) 4.5) 4.1) 0.01 (0.26 to 0.29) 0.928

*By paired t-test adjusted for baseline means.

assignment and gender, female patients experienced significantly (p = 0.000) more pain in the gel group than those in the injection group. A gender related difference in the injection group could not be detected (p = 0.229). Intention to treat analysis (ITT) was performed confirming robustness of the results obtained by per protocol (PP) analysis. Patients’ preference of local anesthesia

In retrospect 69% of the patients favored gel, 28% injection and 3%

were indecisive, with no preference for one anesthesia type (Table 6). Patients who had opted for the anesthesia gel showed no significant difference in VAS pain perception (p = 0.062) between gel group (17.6, SD 16.1) and injection group (9.7, SD 13.1). The choice of injection correlated with significantly (p = 0.005) higher pain scores in the gel group (46.6, SD 22.8) than in the injection group (15.6, SD 20.0). Solely regarding patients with the need for rescue anesthesia (during gel treatment), there was no significant difference (p = 0.138) between

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their VAS pain perception in the gel group (64.8, SD 28.0) and the injection group (41.4, SD 38.4). VRS scores as per anesthesia choice confirm these data. ‘Rescue anesthesia’ was necessary in five out of 38 cases during gel treatment, i.e. 87% were sufficiently anesthetized by the gel. Discussion

Our data show that the use of local anesthesia gel (lidocaine 2.5% and prilocaine 2.5%) for SRP has no influence (p > 0.05) on the reduction of PPD and the change of CAL

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Table 4. Mean clinical attachment level (CAL) by treatment assignment and time Mean CAL

Sequence

Treatment (n)

Quadrants

Gel (n = 19) Injection (n = 19) Injection – gel Gel (n = 19) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

Pockets ≤ 3 mm

Gel (n = 19) Injection (n = 19) Injection – gel Gel (n = 19) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

Gel – injection

Gel (n = 19) Injection (n = 19) Injection – gel Gel (n = 19) Injection (n = 19) Difference baseline/recall in mm (SD)

1, 2, 2, 1,

Pockets ≥ 6 mm

1, 2, 2, 1,

All

Pockets 4–5 mm

Gel – injection

Gel – injection

Gel – injection

Gel (n = 17) Injection (n = 16) Injection – gel Gel (n = 18) Injection (n = 19) Difference baseline/recall in mm (SD)

Baseline Mean  SD (range) 3.8  0.5 3.9  0.5 3.9  0.8 4.0  0.8 Gel Injection 3.1  0.5 3.1  0.6 2.9  0.6 2.8  0.5 Gel Injection 4.5  0.4 4.6  0.4 4.6  0.4 4.7  0.4 Gel Injection 6.9  0.7 6.8  1.0 6.8  0.8 6.8  0.9 Gel Injection

4 3 3 4

4 3 3 4

4 3 3 4

4 3 3 4

(2.8 (3.2 (2.9 (2.8

(2.4 (2.4 (2.3 (2.3

(4.1 (4.0 (4.1 (4.2

(6.0 (6.0 (6.0 (6.0

to to to to

to to to to

to to to to

to to to to

4.7) 5.4) 6.2) 6.6)

4.1) 4.5) 4.4) 4.4)

5.2) 5.6) 5.6) 5.8)

8.4) 9.0) 8.3) 9.5)

Recall Mean  SD (range) 2.8 2.8 3.0 3.1 0.98 1.00 2.5 2.6 2.6 2.7 0.39 0.33 3.0 3.0 3.2 3.2 1.47 1.52 4.0 4.2 3.7 3.9 3.01 2.75

                       

0.7 (1.8 0.8 (2.0 0.8 (1.9 0.8 (1.7 0.41 0.43 0.6 (1.6 0.7 (1.7 0.6 (1.7 0.7 (1.6 0.36 0.43 0.7 (1.9 0.8 (2.1 0.7 (2.2 0.8 (1.8 0.46 0.56 1.7 (2.3 2.2 (2.5 1.3 (1.7 1.2 (2.0 1.24 1.04

to to to to

Difference (CI) p-value*

3.9) 5.4) 5.0) 5.3) 0.00 (0.07 to 0.06) 0.996

to to to to

3.5) 4.5) 3.8) 4.3) 0.06 (0.01 to 0.13) 0.104

to to to to

5.0) 5.6) 4.6) 4.9) 0.02 (0.13 to 0.10) 0.778

to to to to

8.4) 10) 7.0) 6.5) 0.27 (0.11 to 0.66) 0.159

*By paired t-test adjusted for baseline means.

Table 5. VAS-scores (in mm) by treatment assignment and gender* Number of patients Per protocol Female patients Male patients Intention to treat Female patients Male patients

33 16 17 38 19 19

Anesthesia gel (SD/range) 27.9 30.3 25.8 32.8 32.9 32.7

(23.5) (24.5) (23.1) (26.9) (24.1) (30.1)

(1–78) (2–78) (1–72) (1–95) (2–78) (1–95)

Injection (SD/range) 12.8 14.2 11.5 16.6 16.1 17.1

(17.0) (19.1) (15.1) (22.4) (21.6) (23.9)

(0–56) (0–54) (0–56) (0–93) (0–67) (0–93)

p-Value† 0.000 0.014 0.007 0.000 0.017 0.004

*VRS scores confirm the VAS findings, not added in separate table. † Analysis by Wilcoxon signed rank test. VAS, Visual analogue scale; VRS, verbal rating scale. Table 6. VAS-scores (in mm) by treatment assignment and anesthesia choice†

Choice for anesthesia gel Choice for infiltration Rescue anesthesia

Number of patients

Anesthesia gel (SD/range)

Injection (SD/range)

p-Value*

22 10 5

17.6 (16.1) (1–50) 46.6 (22.8) (16–78) 64.8 (28.0) (25–95)

9.7 (13.1) (0–50) 15.6 (20.0) (0–56) 41.4 (38.4) (2–93)

0.062 0.005 0.138

*Analysis by Wilcoxon signed rank test. † VRS scores confirm the VAS findings, not added in separate table. VAS, Visual analogue scale; VRS, verbal rating scale.

compared to injected local anesthesia (articaine plus epinephrine 1:100,000). In moderate pockets (4–5 mm) a reduction of PPD in the gel group of 1.19 mm (0.37) compared to 1.28 mm (0.40) in the injection group was found. These results are in

accordance with systematic reviews and clinical trials on the effect of subgingival debridement (Van der Weijden & Timmerman 2002, Apatzidou & Kinane 2004, Sanz & Teughels 2008, Goodson et al. 2012). The overall weighted mean of pocket depth reduction ranges from 1.18 to

1.81 mm for SRP (Van der Weijden & Timmerman 2002, Goodson et al. 2012). Sanz et al. reported a 1.0 mm reduction for moderate pockets (5– 6 mm) and 2.2 mm for deep pockets (≥7 mm). These data arise from studies evaluation periods of more than 4 months. The short term effect of SRP was investigated by Apatzidou & Kinane (2004). Probing depths and CALs were assessed at baseline and 6 weeks after non-surgical periodontal therapy. The reduction of PPD in moderate pockets (5–7 mm) was reported as 2.3 mm (1.0), in deep pockets (>7 mm) 3.7 mm (1.7). These data are comparable to our findings in moderate (gel: 1.73  0.40, injection 1.85  0.44) and deep pockets (gel: 3.34  1.12, injection 3.22  0.92). Another short term study presented slightly better results after 3 months of evaluation with 2.20 mm (0.38) in moderate pockets (5–6 mm) and 4.37 mm (0.73) in deep pockets (≥7 mm; Zanatta et al. 2006), whereas JervoeStorm et al. (2006) presented a little less improvement (5–7 mm: 1.7  0.48, >7 mm: 2.3  0.99). Overall, our results for pocket depths reduction are in accordance with the existing literature. Divided by treatment assignment, no difference in pocket

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Anesthesia gel and treatment outcome depths reduction between the gel and the injection group could be detected. This denies the presumption that the use of the anesthesia gel (with more intraoperative pain) leads the dentist to a lower process quality in non-surgical periodontal therapy. Clinical attachment gain showed similar results with no difference between gel and injection group. In moderate pockets (4–5 mm) an attachment gain in the gel group of 1.47 mm (0.46) compared to 1.52 mm (0.56) in the injection group was found. These results are supported by systematic reviews and clinical trials on the effect of subgingival debridement (Van der Weijden & Timmerman 2002, Apatzidou & Kinane 2004, Sanz & Teughels 2008, Goodson et al. 2012). The overall weighted mean of clinical attachment gain ranges from 0.64 to 0.92 mm for SRP (Van der Weijden & Timmerman 2002, Goodson et al. 2012). These data arise from studies evaluation periods of more than 4 months. The short term effect of SRP was investigated after 3 months by Zanatta et al. (2006). The clinical attachment gain in moderate pockets (5–6 mm) was reported as 1.61 mm (0.41), 3.01 mm (1.08) in deep pockets (≥7 mm; Zanatta et al. 2006). These data are comparable to our findings in moderate (gel: 1.47  0.46, injection 1.52  0.56) and deep pockets (gel: 3.01  1.24, injection 2.75  1.04). Two other short term studies reported a little less improvement with a clinical attachment gain of 0.7–1.0 mm in moderate pockets (5–7 mm) and 1.1–1.6 mm in deep pockets (>7 mm; Apatzidou & Kinane 2004, Jervoe-Storm et al. 2006). Overall, our results for clinical attachment gain are also in accordance with the existing literature. Divided by treatment assignment, no difference in attachment gain between the gel and the injection group could be detected. This also denies the presumption that the use of the anesthesia gel (with more intraoperative pain) leads the dentist to a lower process quality in non-surgical periodontal therapy. The periodontist was blinded about used anesthesia, so examiner based bias was reduced. Due to the fact that treatment was performed by an experienced periodontal examiner, it is assumed that examiner

influence is allocated equally to both groups. Even if an additional blinding of the patients would have been more appropriate for the pain assessement it was not chosen because of two reasons: (1) Regarding the primary endpoint ‘treatment ourtcome’ (by PPD and CAL), it would have not offered an extra benefit, because the healing process is not influenced by the knowledge of anesthesia used. (2) The secondary endpoint ‘anesthesia choice’ would have been difficult to evaluate. In the gel group patients experienced more intra-operative pain during SRP than with injected anesthesia (for both VAS and VRS scores). As a topical anesthetic, the gel is only able to reduce the soft tissue pain perception and will have no effect on pulpal pain or dentin hypersensitivity. Even in the injection group, patients reported procedural pain for both VAS and VRS scores. This may be caused by the use of infiltration anesthesia in the mandibular rather than block anesthesia. Steenberghe et al. and others, however, showed SRP to be a painful or at least uncomfortable form of treatment even if block anesthesia was used (Matthews & McCulloch 1993, Jacobs & van Steenberghe 1994, van Steenberghe et al. 2004b). Despite significantly lower analgesic efficacy compared to injected anesthesia, the gel was preferred by 69% of the patients. Similar data were reported in other studies. In two multicenter evaluations comparing intra-pocket lidocaine/prilocaine (2.5%) gel versus injected lidocaine with 2% adrenaline, 70–72.4% of the patients preferred the gel (van Steenberghe et al. 2004a, Derman et al. 2013). Stoltenberg et al. (2007) compared 20% benzocaine gel versus injected 2% lidocaine for SRP procedures, with the result being that 52% favored the gel. The main reason for patients’ preference of anesthesia gel was the lack of postoperative numbness in our study (data not shown) and other studies (van Steenberghe et al. 2004a, Stoltenberg et al. 2007, Derman et al. 2013). Second most common was the avoidance of the needle stick (data not shown). Todd et al. (1996) showed that patients accepted mild to moderate pain, if an injection could be avoided this way.

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

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Anesthesia preference was related to experienced pain perception using the anesthesia gel. This finding is confirmed by Stoltenberg et al. (2007) where the same pain-to-choice relation was found. Patients deciding pro anesthesia gel showed no significant difference (p = 0.062) in VAS pain scores between gel and injection. The same effect could be observed in patients with rescue anesthesia. Although mean pain perception was noticeably higher, no significance in VAS (p = 0.138) and VRS (p = 0.066) pain scores could be found. These patients seemed to be generally more susceptible to pain. Rescue anesthesia was performed in three female and two male patients. Patients preferring injection showed significantly higher VAS (p = 0.005) and VRS (p = 0.006) pain perception with anesthesia gel than with injection. Although injected local anesthesia controlled pain more effectively, it is clinically relevant that 87% of the participants did not request rescue anesthesia while gel was used. (van Steenberghe et al. (2004a) found comparable results in their multi-center study – 80% of the participants had a satisfactory anesthesia for SRP procedures with the lidocaine/prilocaine gel. It can be concluded that the anesthesia gel could substitute injected anesthesia for SRP procedures in most cases. Predictors have to be found for those patients where anesthesia gel fails in pain reduction efficacy. Probing pocket depths seem to be a first predictor: increasing pocket depths were accompanied by increasing procedural pain (Derman et al. 2013). For the reason that no patient reported adverse events, the anesthesia gel is also a viable alternative to injected local anesthesia. Despite lower anesthesia depths with the intra-pocket gel our data indicate the same beneficial treatment outcome for PPD and clinical attachment gain. Conclusion

The same beneficial treatment outcome after SRP for PPD and clinical attachment gain could be detected irrespective of the applied type of anesthesia. The majority of patients (69%) prefer the gel in spite of more intense pain experienced during SRP procedures.

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Acknowledgement

The authors are grateful to Dr. Sascha Nieland, Center of Dental Medicine, Operative Dentistry and Periodontology, University of Cologne for supporting this study by anesthetizing the patients. References Apatzidou, D. A. & Kinane, D. F. (2004) Quadrant root planing versus same-day full-mouth root planing I. Clinical findings. Journal of Clinical Periodontology 31, 132–140. Badran, Z., Boutigny, H., Struillou, X., Weiss, P., Laboux, O. & Soueidan, A. (2012) Clinical outcomes after nonsurgical periodontal therapy with an Er:YAG laser device: a randomized controlled pilot study. Photomedicine and Laser Surgery 30, 347–353. Braun, A., Krause, F., Nolden, R. & Frentzen, M. (2003) Subjective intensity of pain during the treatment of periodontal lesions with the Vector-system. Journal of Periodontal Research 38, 135–140. Derman, S., Lowden, C., Kaus, P. & Noack, M. (2013) Pocket-depths-related effectiveness of an intrapocket anaesthesia gel in periodontal maintenance patients. International Journal of Dental Hygiene doi: 10.1111/idh.12036 Donaldson, D., Gelskey, S. C., Landry, R. G., Matthews, D. C. & Sandhu, H. S. (2003) A placebo-controlled multi-centred evaluation of an anaesthetic gel (Oraqix) for periodontal therapy. Journal of Clinical Periodontology 30, 171–175. Friskopp, J. & Huledal, G. (2001) Plasma levels of lidocaine and prilocaine after application of Oraqix, a new intrapocket anesthetic, in patients with advanced periodontitis. Journal of Clinical Periodontology 28, 425–429. Friskopp, J., Nilsson, M. & Isacsson, G. (2001) The anesthetic onset and duration of a new lidocaine/prilocaine gel intra-pocket anesthetic (Oraqix) for periodontal scaling/root planing. Journal of Clinical Periodontology 28, 453–458. Goodson, J. M., Haffajee, A. D., Socransky, S. S., Kent, R., Teles, R., Hasturk, H., Bogren, A., Van Dyke, T., Wennstrom, J. & Lindhe, J. (2012) Control of periodontal infections: a randomized controlled trial I. The primary outcome attachment gain and pocket depth reduction at treated sites. Journal of Clinical Periodontology 39, 526–536. Heft, M. W., Perelmuter, S. H., Cooper, B. Y., Magnusson, I. & Clark, W. B. (1991) Relationship between gingival inflammation and

Clinical Relevance

Scientific rationale for the study: Mechanical SRP procedures need local anesthesia in most cases. Multiple clinical studies proved pain reduction efficacy of intra-pocket anesthesia gel during SRP. Limited data are available comparing treatment outcome after SRP using different types of local anesthesia.

painfulness of periodontal probing. Journal of Clinical Periodontology 18, 213–215. Hujoel, P. P. & DeRouen, T. A. (1992) Validity issues in split-mouth trials. Journal of Clinical Periodontology 19, 625–627. Hujoel, P. P. & Loesche, W. J. (1990) Efficiency of split-mouth designs. Journal of Clinical Periodontology 17, 722–728. Jacobs, R. & van Steenberghe, D. (1994) The effect of electronic dental analgesia during sonic scaling. Journal of Clinical Periodontology 21, 728–730. Jeffcoat, M. K., Geurs, N. C., Magnusson, I., MacNeill, S. R., Mickels, N., Roberts, F., Robinson, P., Salamati, A. & Yukna, R. (2001) Intrapocket anesthesia for scaling and root planing: results of a double-blind multicenter trial using lidocaine prilocaine dental gel. Journal of Periodontology 72, 895–900. Jervoe-Storm, P. M., Semaan, E., AlAhdab, H., Engel, S., Fimmers, R. & Jepsen, S. (2006) Clinical outcomes of quadrant root planing versus full-mouth root planing. Journal of Clinical Periodontology 33, 209–215. Karadottir, H., Lenoir, L., Barbierato, B., Bogle, M., Riggs, M., Sigurdsson, T., Crigger, M. & Egelberg, J. (2002) Pain experienced by patients during periodontal maintenance treatment. Journal of Periodontology 73, 536–542. Kocher, T., Fanghanel, J., Schwahn, C. & Ruhling, A. (2005) A new ultrasonic device in maintenance therapy: perception of pain and clinical efficacy. Journal of Clinical Periodontology 32, 425–429. Kumar, P. S. & Leblebicioglu, B. (2007) Pain control during nonsurgical periodontal therapy. The Compendium of Continuing Education in Dentistry 28, 666–669; quiz 670–661. Magnusson, I., Geurs, N. C., Harris, P. A., Hefti, A. F., Mariotti, A. J., Mauriello, S. M., Soler, L. & Offenbacher, S. (2003) Intrapocket anesthesia for scaling and root planing in pain-sensitive patients. Journal of Periodontology 74, 597–602. Matthews, D. C. & McCulloch, C. A. (1993) Evaluating patient perceptions as short-term outcomes of periodontal treatment: a comparison of surgical and non-surgical therapy. Journal of Periodontology 64, 990–997. Mayor-Subirana, G., Yague-Garcia, J., Valmaseda-Castellon, E., Arnabat-Dominguez, J., BeriniAytes, L. & Gay-Escoda, C. (2013) Anesthetic efficacy of oraqixâ versus hurricaineâ and placebo for pain control during non-surgical periodontal treatment. Medicina oral, patologıa oral y cirugıa bucal 19, e192–e201. Milgrom, P., Coldwell, S. E., Getz, T., Weinstein, P. & Ramsay, D. S. (1997) Four dimensions of fear of dental injections. Journal of the American Dental Association 128, 756–766.

Principal findings: In this splitmouth scaling and root planing study, the choice of anesthesia had no influence on a change of probing pocket depth nor on the clinical attachment level (p > 0.05). Similar beneficial treatment effects could be expected by use of anesthesia gel containing 2.5% lidocaine and 2.5% prilocaine.

Perry, D. A., Gansky, S. A. & Loomer, P. M. (2005) Effectiveness of a transmucosal lidocaine delivery system for local anaesthesia during scaling and root planing. Journal of Clinical Periodontology 32, 590–594. Sanz, M. & Teughels, W. (2008) Innovations in non-surgical periodontal therapy: Consensus Report of the Sixth European Workshop on Periodontology. Journal of Clinical Periodontology 35, 3–7. van Steenberghe, D., Bercy, P., De Boever, J., Adriaens, P., Geers, L., Hendrickx, E., Adriaenssen, C., Rompen, E., Malmenas, M. & Ramsberg, J. (2004a) Patient evaluation of a novel non-injectable anesthetic gel: a multicenter crossover study comparing the gel to infiltration anesthesia during scaling and root planing. Journal of Periodontology 75, 1471– 1478. van Steenberghe, D., Garmyn, P., Geers, L., Hendrickx, E., Marechal, M., Huizar, K., Kristofferson, A., Meyer-Rosberg, K. & Vandenhoven, G. (2004b) Patients’ experience of pain and discomfort during instrumentation in the diagnosis and non-surgical treatment of periodontitis. Journal of Periodontology 75, 1465– 1470. Stoltenberg, J. L., Osborn, J. B., Carlson, J. F., Hodges, J. S. & Michalowicz, B. S. (2007) A preliminary study of intra-pocket topical versus injected anaesthetic for scaling and root planing. Journal of Clinical Periodontology 34, 892– 896. Todd, K. H., Funk, K. G., Funk, J. P. & Bonacci, R. (1996) Clinical significance of reported changes in pain severity. Annals of Emergency Medicine 27, 485–489. Van der Weijden, G. A. & Timmerman, M. F. (2002) A systematic review on the clinical efficacy of subgingival debridement in the treatment of chronic periodontitis. Journal of Clinical Periodontology 29(Suppl 3), 55–71; discussion 90-51. Zanatta, G. M., Bittencourt, S., Nociti, F. H. Jr, Sallum, E. A., Sallum, A. W. & Casati, M. Z. (2006) Periodontal debridement with povidoneiodine in periodontal treatment: short-term clinical and biochemical observations. Journal of Periodontology 77, 498–505.

Address: Sonja H. M. Derman Center of Dental Medicine Operative Dentistry and Periodontology Kerpener Str. 32 D – 50931 Cologne Germany E-mail: [email protected]

Practical implications: Choosing anesthesia gel for SRP procedures does result in adequate periodontal pocket reduction and clinical attachment gain. Patients‘ choice shows a preference for anesthesia gel over injection. This indicates more comfort for patients undergoing SRP without limitations in treatment outcome.

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Influence of intra-pocket anesthesia gel on treatment outcome in periodontal patients: a randomized controlled trial.

Compare the treatment outcome after scaling and root-planing using local anesthesia gel or injected local anesthesia...
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