跳至主要内容
临床试验/NCT07673185
NCT07673185招募中不适用

Clinical and Biochemical Evaluation of the Effect of Omega-3 Fatty Acids Plus Low-Dose Aspirin as an Adjunct to Non-Surgical Periodontal Therapy in Smoker Patients With Stage III Periodontitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
40
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 double-blind placebo-controlled clinical trial aims to evaluate the clinical and biochemical effects of omega-3 fatty acids combined with low-dose aspirin as an adjunct to scaling and root planing (SRP) in smoker patients with Stage III periodontitis. The study compares test and control groups regarding periodontal clinical parameters and gingival crevicular fluid interleukin-1 beta (IL-1β) levels Or other inflammatory markers that will be determined later at baseline, 3 months, and 6 months following treatment

详细描述

characterized by progressive destruction of the supporting structures of the teeth. Smoking is a major risk factor that increases disease severity and impairs periodontal healing. Host modulation therapy using omega-3 fatty acids and low-dose aspirin has been suggested as a promising adjunctive approach to conventional periodontal treatment due to its anti-inflammatory and pro-resolving effects.

This study is a randomized, double-blind, placebo-controlled clinical trial conducted on smoker patients diagnosed with Stage III periodontitis. Participants are allocated into two groups. The test group receives scaling and root planing (SRP) followed by omega-3 fatty acids and low-dose aspirin, while the control group receives SRP and placebo.

Clinical periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL) are assessed at baseline, 3 months, and 6 months. Gingival crevicular fluid samples are collected for biochemical assessment of interleukin-1 beta (IL-1β) levels using ELISA Or other inflammatory markers that will be determined later.

The primary objective is to evaluate changes in probing pocket depth and clinical attachment level. Secondary outcomes include changes in inflammatory biomarker levels and other periodontal clinical parameters. The findings may provide evidence regarding the efficacy of omega-3 fatty acids and low-dose aspirin as adjunctive host modulation therapy in smoker patients with Stage III periodontitis.

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

Double-blind placebo-controlled study. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Male or female smokers aged 30 to 50 years.
  • •Diagnosed with Stage III periodontitis according to the 2017 World Workshop classification.
  • •Probing pocket depth (PPD) ≥ 5 mm.
  • •Clinical attachment loss (CAL) ≥ 5 mm.
  • •Presence of at least 20 natural teeth.
  • •Willing and able to provide written informed consent.

排除标准

  • •- Systemic diseases affecting periodontal health.
  • •Pregnancy or lactation.
  • •Periodontal treatment within the previous 6 months.
  • •Use of antibiotics or anti-inflammatory drugs within the previous 6 months.
  • •Allergy or hypersensitivity to omega-3 fatty acids or aspirin.
  • •Long-term anticoagulant therapy.
  • •History of gastric ulcer or bleeding disorders.
  • •Participation in another clinical trial within the previous 3 month

研究组 & 干预措施

Omega-3 Plus Low-Dose Aspirin

Experimental

Participants receive scaling and root planing followed by omega-3 fatty acids (EPA 640 mg and DHA 480 mg daily) plus low-dose aspirin (75 mg daily) for 6 months.

干预措施: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin (Drug)

Placebo Control

Placebo Comparator

Participants receive scaling and root planing followed by placebo capsules for 6 months.

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Probing Pocket Depth (PPD)

时间窗: Baseline, 3 Months, and 6 Months

Mean change in probing pocket depth measured in millimeters at six sites per tooth.

Change in Clinical Attachment Level (CAL)

时间窗: Baseline, 3 Months, and 6 Months

Mean gain in clinical attachment level measured in millimeters.

次要结局

  • Change in Interleukin-1 Beta (IL-1β) Levels(Baseline, 3 Months, and 6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa hesham Mahmoud

Master's Degree Candidate, Department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology

Al-Azhar University

研究点 (1)

Loading locations...

相似试验