A Phase 4 interventional study of 2.5% flurbiprofen and 98% aloe vera in Periodontitis Chronic Generalized Severe, sponsored by Beirut Arab University. Completed at 1 site in Lebanon. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Beirut Arab University · Phase 4, Interventional, and Treatment
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.
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:
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Beirut Arab University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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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.
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 · Other: Placebo
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 · Other: Placebo
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 · Drug: 98% aloe vera
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)
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)
saline
clinical attachment level
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
Time frame: 6 months
Probing Depth
used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.
Time frame: 6 months
Bleeding on Probing
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).
Time frame: 6 months
Plaque index
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)
Time frame: 6 months
Gingival index
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
Time frame: 6 months
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Beirut Arab University