Efficacy of an Anti-Discoloration System (ADS) to Reduce Dental Staining in a 0.12% Chlorhexidine-based Mouthwash
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dental Staining - spectroscopic evaluation
研究概览
简要总结
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.
A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed.
In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.
详细描述
In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L*a*b* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).
These analyses will be performed at baselines and after each 21-days-long cycle of mouthwash.
A wash-out period between the cycles of 21 days will be performed. In the second "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).
The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to be free from oral mucosa conditions affecting its integrity
- •to avoid drug or mouthwash intake during the study and in the previous month
排除标准
- •specific allergy to mouthrinses
- •presence of periodontitis
- •frequent use of Chlorhexidine-based oral hygiene products
研究组 & 干预措施
Chlorhexidine gluconate with ADS
Chlorhexidine 0.12% plus Anti-Discoloration System Mouthwash
干预措施: Chlorhexidine gluconate with ADS (Drug)
Chlorhexidine gluconate without ADS
Chlorhexidine 0.12% Mouthwash
干预措施: Chlorhexidine gluconate without ADS (Drug)
结局指标
主要结局
Dental Staining - spectroscopic evaluation
时间窗: 21 days
dental color before and after the two treatments
次要结局
- Dental Staining - visual evaluation(21 days)
- Dental Staining - visual evaluation on images(21 days of treatments, re-analysis of images after 6 months from the end of the trial)
研究者
ANDREA SARDELLA
Associate Professor
University of Milan
