Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis (POME-PERIO)

Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis: A Randomized Split-Mouth 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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Pomegranate Peel Extract Gel; Other: Placebo gel

Detailed Description

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
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gehad Samy, BDS, MSc, PhD; Phone Number: +201092710515; Email: gehadasaad.26@azhar.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Recruiting
      • Faculty of Dental Medicine for Girls, Al-Azhar University
      • Contact: Gehad Samy, BDS, MSc, PhD; Phone Number: +201092710515; Email: gehadasaad.26@azhar.edu.eg
      • Principal Investigator: Gehad Samy, BDS, MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomegranate Peel Extract Gel; Periodontal sites receive scaling and root planing followed by subgingival application of pomegranate peel extract gel.	Drug: Pomegranate Peel Extract Gel; Locally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.
Placebo Comparator: Placebo Gel; Periodontal sites receive scaling and root planing followed by subgingival application of placebo gel with identical appearance and consistency.	Other: Placebo gel; Placebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 month, 3 months, and 6 months
Change in Plaque Index (PI)	Change in plaque index (PI) assessed using the Silness and Löe Plaque Index.	Baseline, 1 month, 3 months, and 6 months
Change in Gingival Index (GI)	Change in gingival index (GI) assessed using the Löe and Silness Gingival Index.	Baseline, 1 month, 3 months, and 6 months
Change in Bleeding on Probing (BOP)	Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing.	Baseline, 1 month, 3 months, and 6 months
Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels	Change in gingival crevicular fluid matrix metalloproteinase-8 (MMP-8) concentration measured using enzyme-linked immunosorbent assay (ELISA).	Baseline, 1 month, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: gehad samy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Scaling and root planing; Stage III periodontitis; Local drug delivery; Split-mouth trial; Stage II periodontitis; Pomegranate peel extract
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: P-PD-26-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No