Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bleeding on probing
研究概览
简要总结
To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis
详细描述
- Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
- Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
- Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
- Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the supervisor will place the mouthwash in dark bottle with number so neither the examiner nor the patient will know the type of the mouthwash
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria:
- •Participants need to be systemically healthy with age > 18 years old.
- •Not taking antibiotic and anti-inflammatory drugs in the last three months.
- •At least 20 teeth should be present
- •Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)
排除标准
- •Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)
- •Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.
- •Those currently using any mouthwash.
- •Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.
- •Those having a history of hypersensitivity to any product used in the present study.
- •Those who are smokers or alcoholics.
- •Those who refuse to participate in the trial.
研究组 & 干预措施
control
patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
干预措施: placebo mouthwash as adjunct to scaling and root planing in periodontitis patients (Other)
chlorohexidine mouthwash
patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
干预措施: chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients (Other)
resveratrol mouthwash
patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month
干预措施: resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients (Other)
结局指标
主要结局
bleeding on probing
时间窗: at1 month from the baseline
bleeding on probing
次要结局
未报告次要终点
研究者
Hadeel Mazin Akram
assistant professor
University of Baghdad