Adjunctive Subgingival Pomegranate Peel Extract Gel for Stage II-III Periodontitis: A Randomized Split-Mouth Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: 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.
次要结局
- 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)
研究者
gehad samy
Lecturer of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dental Medicine for Girls, Al-Azhar University
Al-Azhar University