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

NCT07725393 | Recruiting

• 1 other identifier: P-PD-26-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis

Keywords

Stage II periodontitis; Stage III periodontitis; Scaling and root planing; Pomegranate peel extract; Local drug delivery; Split-mouth trial; Randomized clinical trial

Outcome Measures

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.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (5)

• Change in Clinical Attachment Level (CAL)

  Baseline, 1 month, 3 months, and 6 months

• Change in Plaque Index (PI)

  Baseline, 1 month, 3 months, and 6 months

• Change in Gingival Index (GI)

  Baseline, 1 month, 3 months, and 6 months

• Change in Bleeding on Probing (BOP)

  Baseline, 1 month, 3 months, and 6 months

• Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels

  Baseline, 1 month, 3 months, and 6 months

Study Arms (2)

Pomegranate Peel Extract Gel

EXPERIMENTAL

Periodontal sites receive scaling and root planing followed by subgingival application of pomegranate peel extract gel.

Drug: Pomegranate Peel Extract Gel

Placebo Gel

PLACEBO COMPARATOR

Periodontal sites receive scaling and root planing followed by subgingival application of placebo gel with identical appearance and consistency.

Other: Placebo gel

Interventions

Pomegranate Peel Extract Gel DRUG

Locally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.

Pomegranate Peel Extract Gel

Placebo gel OTHER

Placebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.

Placebo Gel

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• gehad samy: lead

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (2)

• Luchian I, Goriuc A, Sandu D, Covasa M. The Role of Matrix Metalloproteinases (MMP-8, MMP-9, MMP-13) in Periodontal and Peri-Implant Pathological Processes. Int J Mol Sci. 2022 Feb 4;23(3):1806. doi: 10.3390/ijms23031806.

  PMID: 35163727 BACKGROUND

• Tyagi P, Dodwad V, Kukreja BJ, Kukreja P. A comparison of the efficacy of scaling and root planning with application of pomegranate chip, pomegranate gel, and scaling and root planing in sufferers with adult periodontitis - A prospective study. J Indian Soc Periodontol. 2021 Jan-Feb;25(1):41-46. doi: 10.4103/jisp.jisp_243_20. Epub 2021 Jan 7.

  PMID: 33642740 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Gehad Samy, BDS, MSc, PhD

CONTACT

+201092710515; gehadasaad.26@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinical operators administering the intervention, investigators responsible for clinical evaluation and data analysis, and outcome assessors are blinded to treatment allocation. Test and placebo gels are identical in appearance, consistency, and packaging. Randomization codes are maintained by an independent investigator until completion of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dental Medicine for Girls, Al-Azhar University

Model Details: This is a randomized, placebo-controlled, triple-blind split-mouth clinical trial. Each participant receives both interventions: pomegranate peel extract gel is applied to randomly assigned periodontal sites, while contralateral sites receive placebo gel after scaling and root planing. Randomization is performed at the site level within each participant.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)