Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis

gehad samy32 enrolled

Overview

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.

Clinical outcomes including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) will be recorded at baseline, 1 month, 3 months, and 6 months. Gingival crevicular fluid samples will also be collected at the same time points for quantitative measurement of matrix metalloproteinase-8 (MMP-8) using enzyme-linked immunosorbent assay (ELISA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Periodontitis

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Presence of at least two non-adjacent periodontal pockets (≥5 mm) located in different quadrants suitable for split-mouth allocation. * Clinical attachment loss consistent with Stage II or Stage III periodontitis. * Ability and willingness to comply with the study protocol and attend all follow-up visits. * Provision of written informed consent. Exclusion Criteria: * 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. * Periodontal therapy received within the previous 6 months. * History of allergy or hypersensitivity to pomegranate or any component of the study materials. * Orthodontic treatment during the study period. * Participation in another clinical trial within the previous 6 months.

Outcomes

Primary Outcomes

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.