NCT06041178

Flurbiprofen Versus Aloe Vera Gel in the Treatment of Chronic Periodontitis in Smoking Patients.

Efficiency of Flurbiprofen 2.5% in Comparison to 98% Aloe Vera Gel as an Adjunctive Therapy to Scaling and Root Planning in the Initial Treatment of Stage III Chronic Periodontitis in Smoking Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beirut Arab University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate clinically the efficacy of flurbiprofen gel in comparison to Aloe Vera gel as adjunctive to SRP in the reduction of periodontal pockets in patients with chronic periodontitis in smoking patients. All patients will receive SRP prior to treatment. * Group 1: one site will receive flurbiprofen while the contralateral site will receive a placebo * Group 2: one site will receive aloe vera while the contralateral site will receive a placebo * Group 3: one site will receive flurbiprofen while the contralateral site will receive aloe vera Researchers will compare the inter and intra-groups differences to check if there's a variation in the periodontal parameters measured.

Detailed description

Complete medical and dental histories as well as informed consent will be collected from eligible participants, and periodontal charting will be done for them. Medical history and laboratory screening for all patients will be carried out at baseline. All participants will undergo scaling and root planning. The selected patients will be allocated into three groups with the help of a computerized randomizer (Randomizer.org) and sites will be assigned as control or test based on a coin flip method: * Group 1 (G1): 20 patients who received treatment involving the application of flurbiprofen gel as an adjunct to scaling and root planing. Specifically, on the test site of each patient, one milliliter of 2.5% flurbiprofen gel was applied, while on the contralateral side, placebo gel was administered as the control intervention. * Group 2 (G2): 20 patients who received treatment involving the application of aloe Vera gel as an adjunct to scaling and root planing. Specifically, on the test site of each patient, one milliliter of 98% aloe Vera was applied, while on the contralateral side, placebo gel was administered as the control intervention. * Group 3 (G3): The intervention involved applying flurbiprofen gel on one site, while the contralateral side received an application of 98% aloe vera. The clinical examiner will not be informed of the treatment groups' distribution. Patients will be informed on self-performed plaque control measures. In the 4th week, 8th week, 12th week, 6 months week clinical examination will be performed to measure the periodontal pocket depth, gingival index, plaque index, clinical attachment level (CAL),and bleeding on probing. Statistical analysis was done using SAS 9.4 Software (SAS Institute Inc., Cary, NC, USA). Means and standard deviations (SD) were calculated for all continuous variables (periodontal parameters: CAL, PD, BOP, GI, PI) at the baseline, fourth week, eighth week, and twelfth week and 6 months. Repeated linear mixed-effects models (PROC MIXED in SAS) were used to examine the changes in all periodontal parameters over the five-time points within each group and between groups. An unstructured covariance matrix was used, residual plots were visually reviewed to check model fit, and extreme outliers were eliminated using the restricted likelihood distance. A Tukey-Kramer 8 correction was applied to all pairwise comparisons. One-way ANOVA was used to examine group differences in PD reduction and CAL. A p-value of 0.05 was considered statistically significant.

Conditions

• Periodontitis Chronic Generalized Severe

Interventions

Type	Name	Description
DRUG	2.5% flurbiprofen	Gel was made of 20% poloxamer and 10% ethanol as an Optimum formulation with sustained release up to 48 hours and a reasonable sol gel transition phase (adjunctive to SRP)
DRUG	98% aloe vera	the Aloe vera gel employed possessed a concentration of 98% and was obtained from the reputable brand Avivir (Denmark). The remaining 2% comprised normal saline. The process of obtaining the 98% Aloe vera gel involved meticulous washing of mature Aloe Vera leaves under running water, followed by the removal of their outer skin. Subsequently, each leaf was divided into smaller pieces, from which the gel was allowed to seep out and carefully collected in a sterile container. The collected gel was then stored at 4°C until the time of its application in the study (adjunctive to SRP)
OTHER	Placebo	saline

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-05-25
• Completion: 2023-07-19
• First posted: 2023-09-18
• Last updated: 2023-09-18

Locations

1 site across 1 country: Lebanon