The Effect of Non-biocidal Adjuncts on the Formation, Composition, Functionality, and Microscale Architecture of Dental Biofilms: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in in-vivo dental biofilm accumulation
研究概览
简要总结
A double-blind, placebo-controlled randomized cross-over trial evaluating the effect of enzyme-containing lozenge on in vivo and in situ grown dental biofilm accumulation. The study includes two phases, one each for the investigation of in-vivo and in-situ grown dental biofilm
详细描述
Up to 50 subjects (aged ≥ 18 years old) with 3 or more active caries lesion, will be randomized to receive:
Phase 1: The effect of multiple-enzyme treatment on plaque accumulation in vivo
Phase 1 includes two experimental periods lasting for one day each, with a washout period of two weeks in between. Each experimental period will include two visits, at day 0 and day 1.
At day 0, the participants will receive a professional tooth cleaning and be randomized to receive Sequence 1 or Sequence 2 in a double-blind randomized cross-over design:
Sequence 1: 3 active enzyme-containing lozenges per day for one day (app. 24h) followed by a washout period of two weeks, followed by 3 identical placebo lozenges per day for one day (app. 24h).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •Males and females ≥ 18 years old.
- •Have three or more active carious lesions.
- •Anatomically possible to manufacture an intraoral lower-jaw splint.
- •Able to understand and follow instructions, as well as to read and sign the informed consent form.
- •A plaque index score ≥ 2 according to the Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI), following 8 to 12 hours plaque accumulation period.
排除标准
- •History of allergies towards any of the ingredients in the test products
- •Self-reported pregnant or nursing
- •Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
- •Orthodontic appliances, including retainers, or removable partial dentures.
- •Self-reported serious medical conditions
结局指标
主要结局
Change in in-vivo dental biofilm accumulation
时间窗: 1 day
To investigate the effect of an enzyme-containing lozenge on dental biofilm accumulation in caries-active subjects in vivo assessed by the planimetric plaque index (PPI)
次要结局
- Change in in-vivo dental biofilm accumulation(1 days)
- Change in in-situ grown dental biofilm accumulation(2 days)
- Change in oral microbial community composition of in-situ grown dental biofilm(2 days)