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NCT Number: NCT07725393

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Gehad Samy, BDS, MSc, PhD

CONTACT

[email protected]

+201092710515

Gehad Samy, BDS, MSc, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pomegranate Peel Extract Gel

Drug

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

Placebo gel

Other

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

Primary outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in probing pocket depth (PPD), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.

Secondary outcomes

  1. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in clinical attachment level (CAL), measured in millimeters using a calibrated periodontal probe at the selected periodontal sites.

  2. Change in Plaque Index (PI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in plaque index (PI) assessed using the Silness and Löe Plaque Index.

  3. Change in Gingival Index (GI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in gingival index (GI) assessed using the Löe and Silness Gingival Index.

  4. Change in Bleeding on Probing (BOP)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in bleeding on probing (BOP), assessed as the presence or absence of bleeding following gentle periodontal probing.

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

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Change in gingival crevicular fluid matrix metalloproteinase-8 (MMP-8) concentration measured using enzyme-linked immunosorbent assay (ELISA).

Study contacts

Contact information is provided by the study sponsor or research team.

Gehad Samy, BDS, MSc, PhD

CONTACT

[email protected]

+201092710515

Sponsors and collaborators

Lead sponsor

gehad samy

Other

Registry information

Official study title

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

Acronym: POME-PERIO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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