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临床试验/NCT07827391
NCT07827391进行中(未招募)不适用

A Retrospective Comparative Evaluation of the Effects of Adjunctive Omega-3 and Resveratrol Supplementation to Non-Surgical Periodontal Therapy on Clinical Periodontal Parameters in Systemically Healthy Patients With Periodontitis.

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Clinical attachment level (CAL)

研究概览

简要总结

This retrospective comparative study aims to evaluate the effects of resveratrol and omega-3 supplementation as adjuncts to non-surgical periodontal treatment on clinical periodontal parameters in patients with periodontitis. A total of 60 systemically healthy, non-smoking patients will be evaluated and categorized into three groups according to their recorded supplementation status: a resveratrol group receiving non-surgical periodontal treatment plus resveratrol supplementation (n=20), an omega-3 group receiving non-surgical periodontal treatment plus omega-3 supplementation (n=20), and a non-supplemented control group receiving non-surgical periodontal treatment alone (n=20). Periodontal outcomes will be assessed at baseline and at 1 and 3 months after non-surgical periodontal treatment using probing pocket depth, clinical attachment level, plaque index, gingival index, and bleeding on probing. The study aims to compare the clinical periodontal outcomes of the three groups and determine whether adjunctive resveratrol or omega-3 supplementation is associated with additional clinical benefits beyond non-surgical periodontal treatment alone.

详细描述

The aim of this retrospective comparative study is to evaluate the clinical effects of resveratrol and omega-3 supplementation administered as adjuncts to non-surgical periodontal treatment on periodontal clinical parameters in patients with periodontitis, and to compare these two adjunctive approaches both with non-supplemented non-surgical periodontal treatment and with each other. In addition to microbial dental biofilm, host inflammatory and immune responses play important roles in the progression of periodontitis. Therefore, periodontal treatment aims not only to reduce the microbial burden but also to control excessive inflammatory responses, promote the resolution of inflammation, and limit periodontal tissue destruction. In this context, adjunctive approaches with anti-inflammatory and antioxidant properties may contribute to improving the clinical outcomes of periodontal treatment.

Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the principal components of omega-3 fatty acids, may contribute to the resolution of inflammation and restoration of periodontal tissue homeostasis by modulating the production of inflammatory lipid mediators and promoting the formation of specialized pro-resolving mediators, including resolvins, protectins, and maresins. Resveratrol, on the other hand, possesses anti-inflammatory and antioxidant properties and may contribute to the regulation of inflammatory responses through effects on NF-κB-related inflammatory signaling pathways, oxidative stress, and cellular signaling mechanisms. These properties provide a rationale for evaluating resveratrol and omega-3 supplementation as adjunctive approaches to non-surgical periodontal treatment.

A total of 60 systemically healthy, non-smoking patients diagnosed with periodontitis were included in the study and categorized into three groups according to their recorded supplementation status, with 20 patients in each group. The first group consisted of patients who received resveratrol supplementation in addition to non-surgical periodontal treatment; the second group consisted of patients who received omega-3 supplementation in addition to non-surgical periodontal treatment; and the third group consisted of patients who received non-surgical periodontal treatment alone without additional supplementation. Patients who had received periodontal treatment within the previous 6 months, had used antibiotics, anti-inflammatory agents, or systemic corticosteroids within the previous 6 months, or had any systemic disease were excluded from the study.

Periodontal clinical parameters were evaluated at baseline and at 1 and 3 months after non-surgical periodontal treatment. The evaluated parameters included probing pocket depth, clinical attachment level, plaque index, gingival index, and bleeding on probing. The study aims to compare the periodontal clinical outcomes among the three groups and to determine whether adjunctive resveratrol or omega-3 supplementation is associated with additional clinical benefits beyond those achieved with non-surgical periodontal treatment alone. Furthermore, the study aims to compare resveratrol and omega-3 supplementation with each other in terms of their associated clinical periodontal outcomes. This three-group comparison is intended to provide a comprehensive clinical evaluation of the potential contribution of these adjunctive supplementation approaches to periodontal treatment outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of at least 20 natural permanent teeth,
  • Age between 18 and 65 years,
  • Non-smoker status,
  • No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the previous 6 months,
  • No known history of hypersensitivity or allergic reactions to resveratrol, omega-3 fatty acids, or dietary supplements containing these components,
  • No periodontal treatment within the previous 6 months,
  • Absence of any oral or other systemic disease,
  • Not being pregnant or lactating.

排除标准

  • Presence of fewer than 20 natural permanent teeth,
  • Age younger than 18 years or older than 65 years,
  • Current smoking,
  • Use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the previous 6 months,
  • Known hypersensitivity or allergic reactions to resveratrol, omega-3 fatty acids, or dietary supplements containing these components,
  • Periodontal treatment within the previous 6 months,
  • Presence of any oral or systemic disease,
  • Pregnancy or lactation.

研究组 & 干预措施

Omega-3 fatty acids

Patients who received omega-3 fatty acid supplementation at a total dose of 1320 mg, including 640 mg EPA and 480 mg DHA, during non-surgical periodontal treatment.

干预措施: Omega-3 (EPA+DHA) (Dietary Supplement)

Trans-resveratrol

Patients who received trans-resveratrol supplementation at a total daily dose of 250 mg twice daily (500 mg/day total), during non-surgical periodontal treatment.

干预措施: trans-resveratrol (Dietary Supplement)

No supplementation

Patients who underwent non-surgical periodontal treatment without receiving resveratrol or omega-3 supplementation

干预措施: No supplementation (Dietary Supplement)

结局指标

主要结局

Clinical attachment level (CAL)

时间窗: Baseline, 1 month, and 3 months

Clinical attachment level (CAL) was measured in millimeters using a Williams periodontal probe as the distance between the cementoenamel junction (CEJ) and the base of the periodontal pocket. In sites with gingival recession, the distance from the CEJ to the gingival margin was incorporated into the CAL measurement. Measurements were recorded at six sites per tooth: mesiobuccal/mesiolabial, mid-buccal/midlabial, distobuccal/distolabial, mesiolingual/mesiopalatal, mid-lingual/mid-palatal, and distolingual/distopalatal sites.

次要结局

  • Probing Pocket Depth (PPD)(Baseline, 1 month, and 3 months)
  • Plaque Index (PI)(Baseline, 1 month, and 3 months)
  • Gingival Index (GI)(Baseline, 1 month, and 3 months)
  • Bleeding on Probing (BOP)(Baseline, 1 month, and 3 months)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pelin Akpak

Research Assistant

Izmir Katip Celebi University

研究点 (1)

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