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

Sponsor

Beirut Arab University (Other)

Overall Status

Completed

CT.gov ID

NCT06041178

Collaborator

(none)

Enrollment

Location

Arms

9.6

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Chronic Generalized Severe	Drug: 2.5% flurbiprofen Drug: 98% aloe vera Other: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2022

Actual Primary Completion Date :

May 25, 2023

Actual Study Completion Date :

Jul 19, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site	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) Other: Placebo saline
Experimental: scaling and root planing + 98% aloe vera on one site and placebo on contralateral site Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site	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
Experimental: scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site	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)

Arm

Intervention/Treatment

Experimental: scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site

Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site

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)

Other: Placebo

saline

Experimental: scaling and root planing + 98% aloe vera on one site and placebo on contralateral site

Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site

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

Experimental: scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site

Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site

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

Outcome Measures

Primary Outcome Measures

clinical attachment level [6 months]
used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket
Probing Depth [6 months]
used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.

Secondary Outcome Measures

Bleeding on Probing [6 months]
It is an indicator of periodontal tissue inflammatory response. The probe is carefully introduced to the bottom of the pocket and gently moved laterally along the pocket wall. Depending on the severity of inflammation, bleeding can vary from a tenuous red line along the gingival sulcus to profuse bleeding (immediately after probing or few seconds after).
Plaque index [6 months]
used to evaluate the level and rate of plaque formation on tooth surfaces. It measures the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The amount of plaque is determined with disclosing solution and a range of scores of 0-5 is assigned with 0 denoting no plaque and 5 denoting heavy plaque (covering 2/3 of the tooth crown)
Gingival index [6 months]
used to assess the severity of gingival inflammation. Scores ranges from 0-3 with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. This measurement is based on the presence or absence of bleeding on gentle probing

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria: 60 patients were selected who had clinical periodontal loss and radiographic bone loss of stage III/grade C with no history of systemic disease. They had at least 2 periodontal sites with a pocket depth of six mm or greater, radiographic evidence of bone loss extending to the middle third of the root, and clinical attachment loss of five mm or more. Eligible subjects were categorized as current smokers if they consistently smoked more than 10 cigarettes per day for a minimum of 5 years. Additionally, individuals with no record of undergoing any periodontal treatment within the six months preceding the study were considered for inclusion.

Exclusion criteria: Patients with systemic illnesses such as diabetes mellitus or conditions that could potentially impair wound healing were excluded from participation. Additionally, individuals who were pregnant or lactating were not considered for inclusion in the study. Subjects who had been prescribed systemic antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the three months preceding the study were also excluded. Furthermore, individuals with confirmed or suspected hypersensitivity to Flurbiprofen or aloe Vera, the focus of the investigation, were not included in the study population.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beirut Arab University	Beirut		Lebanon

Sponsors and Collaborators

Beirut Arab University

Investigators

Study Chair: Nayer Aboelsaad, PhD, Professor and Chairman of Periodontology department - BeirutArabU

Study Documents (Full-Text)

More Information

Publications

Responsible Party:

Beirut Arab University

ClinicalTrials.gov Identifier:

NCT06041178

Other Study ID Numbers:

2022-H-0100-D-R-0487

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Flurbiprofen

Study Results

No Results Posted as of Sep 18, 2023