NCT05874882招募中早期 1 期
Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
适应症
试验速览
- 阶段
- 早期 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)
- •The exclusion criteria:
- •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.
排除标准
- 未提供
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
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic RhinitisSeasonal Allergic RhinitisNCT02130440University of Campania "Luigi Vanvitelli"100
招募中
不适用
Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school WheezingWheezingRecurrent Respiratory Tract InfectionsNCT05684848Noos S.r.l.252
进行中（未招募）
不适用
Effect of resveratrol on cognitive functions and inflammation in a population of older adults with type 2 diabetes mellitusISRCTN15172592ational Autonomous University of Mexico120
已完成
不适用
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related FactorsSkin ConditionsProinflammatory CytokinesNCT04456829TCI Co., Ltd.60
招募中
3 期
Resveratrol in COVID19IRCT20200112046089N1Ahvaz University of Medical Sciences50