a Proof of Principle in Vivo Study to Evaluate the Anti-Calculus and Safety Profile of a Novel Enzyme Formulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Tartarase Efficacy
研究概览
简要总结
This study was designed to find our whether a novel toothpaste containing safe digestive enzymes (Tartarase) was able to remove pre-existing dental tartar when compared to a well-known toothpaste (Crest). A group of 40 test subjects that had at lease 9 mm of tartar on the tongue side of the 6 lower front teeth, were randomly divided into 3 groups unknown to the the team overseeing the measurements. All the groups brushed with a toothbrush approved by the American Dental Association. Group A (20 subject) was the control group. They brushed in the morning and before bed with Crest for 2 minutes. Group B (10 subjects) brushed in the morning and before bed using the same procedure, first with Tartarase for 30 seconds, spit, but did not rinse, then repeated. After 30 minutes then brushed with Crest. Group C (10 subjects) brushed for 30 seconds with Tartarase, spit but did not rinse, then filled a dental tray with Tartarase and covered the 6 lower front teeth and waited 30 minutes, spit but did not rinse and brushed for ann additional 30 seconds with Tartarase. After 30 minutes they brushed with Crest. They brushed with crest before bed, without another Tartarase treatment. The study was a 4-week study, with tartar measured at the start (baseline), again after 2 weeks and again at the final study point of 4 weeks.
If any of the study subjects experienced anything unpleasant, they were to inform the team overseeing the study. The tartar measurements were compiled into the 3 groups and statistically analyzed to determine if there were any changes in the amount of tartar within the groups and between the groups.
详细描述
Quality assurance All raw data (Case Report Forms) were screened for quality assurance by the Investigators' Quality Assurance officer (QA) and found to be in compliance with protocol requirements before being sent to the Sponsor.
Data checks Not applicable Source data verification Not applicable Data dictionary
The Volpe-Manhold Index (V-MI) measures, in millimeters, calculus present on the lingual surfaces of the lower six anterior teeth. The measurement from the most inferior border of visible calculus obtained in three planes:
- Bisecting the center of the lingual surface;
- Diagonally through the mesial-incisal point angle of the tooth through the area of greatest calculus height; and
- Diagonally through the distal point angle of the tooth through the area of greatest calculus height.
The primary outcome was calculus using the V-MI, all other variables are considered secondary. The calculus scores are summed to provide a total score at each clinical examination. The primary time points were at the baseline and at the after 4 weeks of product use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The group of study subjects, selected from the study site's database were randomized by the statistician into three different treatment groups. The personnel performing the measurements were blinded as to which group the study subjects we in.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be included in the study, each subject must have:
- •Provided written informed consent to participate in the study;
- •Adult subjects aged 18 years and older, that were in good health;
- •Agreed not to participate in any other oral/dental product studies during the course of this study and used only the assigned oral hygiene products during the entire study (including toothbrushes, toothpastes, home remedies, floss or other products like chewing gum, mouthwashes, tongue cleaners, etc.);
- •Agreed to refrain from the use of any elective dentistry (including a non-study dental prophylaxis) until the study had been completed;
- •Agreed to refrain from the use of any non-study oral hygiene and whitening products;
- •Been in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study;
- •Had six mandibular anterior teeth with no crowns or veneers;
- •Agreed to comply with the study procedures and schedule, including the follow up visits;
- •Had at least 9mm of dental calculus on the mandibular anterior six teeth and reported that they had received a dental cleaning in previous 2-6 months.
- •Healthy Volunteers
排除标准
- •Had a medical condition requiring antibiotic premedication prior to dental procedures;
- •Regularly used chlorhexidine mouth rinse;
- •Had any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal disease);
- •Had current or history of oral cavity cancer or oropharyngeal cancer;
- •Were pregnant or nursing by subject report;
- •Did not brush regularly;
- •Had any condition that might have made it unsafe for the subject to participate in this study, at the discretion of the investigator.
结局指标
主要结局
Tartarase Efficacy
时间窗: 4 weeks
Assess the change in calculus abundance measured by the V-MI in groups brushing with Crest, the Tartarase brushing group and the Tartarase tray group.
次要结局
未报告次要终点