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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• Change in Probing Pocket Depth (PPD) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]

Вторичные конечные точки (5)

• Change in Clinical Attachment Level (CAL) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Plaque Index (PI) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Gingival Index (GI) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Bleeding on Probing (BOP) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Gingival Crevicular Fluid Matrix Metalloproteinase-8 (MMP-8) Levels [Срок оценки: Baseline, 1 month, 3 months, and 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo

Публикации

• 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

Идентификаторы

NCT: NCT07725393 · P-PD-26-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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