Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis
ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
Sponsorgehad samy
About this trial
This randomized, triple-blind, placebo-controlled split-mouth clinical trial aims to evaluate the clinical and biochemical efficacy of subgingival pomegranate peel extract gel as an adjunct to scaling and root planing (SRP) in the treatment of Stage II-III periodontitis.
Thirty-two participants diagnosed with Stage II-III periodontitis will receive SRP in all selected periodontal sites. Test sites will receive locally delivered pomegranate peel extract gel, while contralateral control sites will receive a placebo gel. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP), and gingival crevicular fluid levels of matrix metalloproteinase-8 (MMP-8), will be assessed at baseline, 1 month, 3 months, and 6 months to evaluate whether adjunctive pomegranate peel extract gel improves periodontal healing compared with SRP alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 30 to 60 years.
Systemically healthy individuals.
Diagnosis of Stage II or Stage III periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
Presence of at least 20 natural teeth.
Disqualifiers
Current smokers or users of any tobacco products.
Pregnant or lactating women.
Patients with systemic diseases known to affect periodontal status or wound healing (e.g., uncontrolled diabetes mellitus, immunodeficiency disorders, osteoporosis requiring antiresorptive therapy).
Use of systemic antibiotics, corticosteroids, immunosuppressive agents, or non-steroidal anti-inflammatory drugs within the previous 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Pomegranate Peel Extract Gel
DrugLocally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.
Placebo gel
Other interventionPlacebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Pomegranate Peel Extract GelExperimental treatment 1 intervention
Group B: Placebo GelPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Probing Pocket Depth (PPD)
Change in probing pocket depth (PPD), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSecondary outcomes
1
Change in Clinical Attachment Level (CAL)
Change in clinical attachment level (CAL), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.
Time frame
Baseline, 1 month, 3 months, and 6 months2
Change in Plaque Index (PI)
Change in plaque index (PI) assessed using the Silness and Löe Plaque Index.
Time frame
Baseline, 1 month, 3 months, and 6 months3
Change in Gingival Index (GI)
Change in gingival index (GI) assessed using the Löe and Silness Gingival Index.
Time frame
Baseline, 1 month, 3 months, and 6 months4
Change in Bleeding on Probing (BOP)
Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
gehad samy
Lead sponsor
Al-Azhar University
Sponsor institution
Source ClinicalTrials.gov