Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash: a Randomized, Double-blind, Controlled, Crossover Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total plaque accumulation
研究概览
简要总结
This study evaluates the antiplaque efficacy of a bioflavonoid-based mouthwash compared to a positive control (0.12% chlorhexidine mouthwash). Following a baseline oral health assessment, participants will use the assigned mouthwash twice daily for 4 consecutive days while refraining from all mechanical oral hygiene practices (e.g., tooth brushing). The trial follows a 2-phase crossover design, where participants use one mouthwash in the first phase and the other in the second phase, separated by a 15-day washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with > 20 teeth present, with a minimum of 5 teeth per quadrant.
- •Individuals >18 years of age
排除标准
- •Individuals with systemic diseases (ASA III o IV).
- •Individuals with systemic diseases or undergoing pharmacological treatment that may modify gingival health.
- •Individuals with periodontal disease (probing depth > 5mm and/or clinical attachment loss >2mm).
- •Individuals currently under orthodontic treatment.
- •Individuals with removable dental prostheses.
- •Individuals with known allergies to any ingredient in the study mouthwashes.
- •Individuals presenting with oral mucosal lesions.
- •Individuals who have used antibiotics, antifungals, corticosteroids, or contraceptives within 3 months prior to the study.
- •Individuals who have used chlorhexidine mouthwash or any other oral antiseptic within 15 days prior to the start of the study.
- •Individuals with any active carious lesions or any cervical restorations present on any tooth.
研究组 & 干预措施
Sequence 1 (Bioflavonoid moutwash then Chlorhexidine)
Participants receive Bioflavonoid mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 2.
干预措施: Bioflavonoid mouthwash (Drug)
Sequence 1 (Bioflavonoid moutwash then Chlorhexidine)
Participants receive Bioflavonoid mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 2.
干预措施: Chlorhexidine 0.12% mouthwash (Drug)
Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)
Participants receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Bioflavonoid mouthwash twice daily for 4 days in Phase 2.
干预措施: Bioflavonoid mouthwash (Drug)
Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)
Participants receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Bioflavonoid mouthwash twice daily for 4 days in Phase 2.
干预措施: Chlorhexidine 0.12% mouthwash (Drug)
结局指标
主要结局
Total plaque accumulation
时间窗: Day 4 of Phase 1 and Day 4 of Phase 2
Plaque levels were recorded using the Turesky modification of the Quigley and Hein plaque index (TQHPI). Scores range from 0 to 5, where 0 = no plaque and 5 = plaque covering two-thirds or more of the crown surface. Higher scores indicate greater plaque accumulation.
Gingival Inflammation Score
时间窗: Day 1 and Day 4 of Phase 1; Day 1 and Day 4 of Phase 2
Gingival inflammation was evaluated on the buccal and lingual surfaces using the Loe Gingival Index via gentle probing. Scoring criteria was defined as: 0= normal gingiva, 1= mild inflammation- slight change in color, oedema no bleeding on probing, 2= moderate inflammation- redness, oedema, bleeding on probing, 3= severe inflammation- marked redness, oedema, ulceration, tendency to spontaneous bleeding.
次要结局
- Participant User Experience Questionnaire(Day 4 of Phase 1 and Day 4 of Phase 2)
研究者
Mayra Schemel Suarez
PhD, DDS
University of Barcelona