Menu
Recruiting NCT07725393

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

No phase Interventional Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pomegranate Peel Extract Gel, Placebo gel.
Who it may be relevant to
Registry conditions: Periodontitis. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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).

Interventions

  • Drug Pomegranate Peel Extract Gel
    Locally delivered subgingival gel containing pomegranate peel extract administered after scaling and root planing.
  • Other Placebo gel
    Placebo gel without active ingredient, identical in appearance and consistency to the experimental gel, administered after scaling and root planing.

Primary outcome measures

  • Change in Probing Pocket Depth (PPD) [Time frame: Baseline, 1 month, 3 months, and 6 months]
Secondary outcome measures (5)
  • Change in Clinical Attachment Level (CAL) [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Change in Plaque Index (PI) [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Change in Gingival Index (GI) [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Change in Bleeding on Probing (BOP) [Time frame: Baseline, 1 month, 3 months, and 6 months]
  • Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels [Time frame: Baseline, 1 month, 3 months, and 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo

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. PMID 35163727
  • 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

Identifiers

NCT: NCT07725393 · P-PD-26-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗