A study validating the efficacy of a herbal mouthwash in reduction of plaque and gingivitis: An in vitro evaluation and a randomized controlled clinical trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement of gingival and plaque indices
研究概览
简要总结
The aim of the present study is to evaluate the efficacy of herbal mouthwashes with chlorhexidine mouthwash in patients with mild to moderate gingivitis for reduction of plaque and gingivitis scores, Microbial counts and salivary pH reduction and to assess patient acceptance (irritation of taste, subjective tooth staining). One hundred twenty individuals with chronic generalized gingivitis will be randomly assigned to three groups: 1) group I, Chlorhexidine mouthwash; 2) group II, Herbal mouthwash A; and 3) group III, Herbal mouthwash B. All individuals will be instructed to rinse with 15 ml of their respective mouthwash twice daily. 1) plaque index (PI); 2) gingival index (GI); 3) oral hygiene index-simplified (OHI-S); and 4) microbiologic colony counts will be recorded at baseline and at 7, 30, and 60 days.
Subsequent to baseline estimation (set 1), each participant will undergo two sets of saliva sample collection along with estimation of salivary pH in two phases: Ten minutes after the mouthrinse (set 2), and 60 min after the mouthrinse (set 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •After taking a detailed medical history and initial clinical and radiologic examination, systemically healthy individuals of an age range of 18-40 years with previously untreated gingivitis and greater than or equal to 20 teeth with no visible signs of untreated dental caries will be selected.
- •Clinical parameters for inclusion will be: 1) gingival index (GI) greater than 1; 2) probing depth less than equal to 3 mm; 3) clinical attachment loss should be 0, with no evidence of radiographic bone loss.
- •Absence of bone loss will be considered when the distance between cemento-enamel junction and crestal bone is less than equal to 1 mm.
排除标准
- •Use of antibiotics and anti-inflammatory drugs in previous 6 months; 2) individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation and plaque control; 3) allergy to any ingredient used in the study; 4) alcoholics; 5) smokers or users of tobacco in any form; 6) individuals with mental retardation or medical illness; 7) Use of mouthwashes and vitamin supplements in last 3 months; 8)History of any periodontal therapy in last months; and 7) pregnant or lactating females.
结局指标
主要结局
Improvement of gingival and plaque indices
时间窗: Baseline, 1 week, 1 month, 2 months
次要结局
- Microbial count.(Baseline-7 days-30 days-60 days)
- Patient acceptance (irritation of taste, subjective tooth staining)(60 days)