Improvement in oral hygiene with toothpaste containing a plaque indicator - a controlled clinical study
- Conditions
- no disease: oral hygiene
- Registration Number
- DRKS00028633
- Lead Sponsor
- niversität Witten/HerdeckeFakultät für GesundheitDepartment für Zahn-, Mund- und KieferheilkundeAbt. für Zahnerhaltung und Präventive Zahnmedizin
- Brief Summary
Objectives To evaluate the efficacy of a plaque revealing toothpaste in reducing plaque and improving oral hygiene compared to a conventional toothpaste. Methods A total of 80 subjects participated in the investigator-blind study using a parallel group design examiner-blind study. Participants were stratified according to gender and age and randomly assigned to two groups: (1) toothbrushing with a plaque revealing toothpaste (Mara expert ® Plaque Checker); (2) toothbrushing with a conventional toothpaste (Odol-med3 Original). A screening, baseline, interim and final examination took place over an eight-week period. Screening and baseline examinations were combined whenever possible. During each examination the Quigley-Hein-Index modified by Turesky (mQHI), the Proximal-Plaque-Index modified by Zimmer et al. (mPPI) as well as the Papillary Bleeding Index by Saxer und Mühlemann (PBI) were recorded. In addition, toothpaste consumption was determined at the interim and final examination to evaluate compliance. At baseline examination a questionnaire was handed out. For statistical analysis the differences between baseline and interim (U1_U2) as well as baseline and final (U1_U3) examination were compared between the two groups. The Independant-Samples-Median-Test was used. For evaluation of the questionnaire the Pearson-Chi-Square-Test was used. Results After four drop-outs and no protocol violation 76 participants (1: n=38, 2: n=38) were included into final analysis. Both groups improved their oral hygiene over the course of the study. The improvements of t group 1 differed significantly on all three indices compared to group 2. U1-U2 ?1mQHI (1) 0,58, (2) 0,22; U1-U3 ?2mQHI (1) 0,73, (2) 0,17; U1-U2 ?1mPPI (1) 0,43, (2) 0,18; U1-U3 ?2mPPI (1) 0,54, (2) -0,02; U1-U2 ?1PBI 0,44, (2) 0,15; U1-U3 ?2PBI (1) 0,49, (2) 0,25. Only 47% of users would continue to integrate the Mara expert ® toothpaste into their daily brushing routine. The taste of this toothpaste was not rated as good. Conclusions The significantly positive improvement in oral hygiene of group 1 compared to group 1 shows that oral hygiene can be improved with the help of a toothpaste that stains biofilm in use. Despite the positive results, the test toothpaste was not rated well by the subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
• At least 16 uncrowned teeth
• Papillary bleeding index = 0.5
• Quigley-Hein Plaque Index (modified from Turesky) =2
• Existing declaration of consent for study participation
• Pregnancy and lactation or planning a pregnancy during the study period
• Uncontrolled diabetes (types I and II)
• Existing removable dentures
• Fixed or removable orthodontic appliances
• Aggressive or severe chronic periodontitis
• Previous participation in the study
• Participation in another clinical study or use of another investigational product within the last 30 days prior to the first study
• Use of antibiotics within the last 14 days before the first examination or other medication or therapy that could influence the study results.
• Known or suspected allergy to one or more toothpaste ingredients
• Alcohol or drug abuse within one year prior to the start of the first investigation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the PBI (Papillary Bleeding Index) as an expression of the quality of oral hygiene
- Secondary Outcome Measures
Name Time Method Change in mAPI (modified approximal plaque index) and mQHI (modified Quigley-Hein plaque index) as an expression of the quality of oral hygiene<br>Results Questionnaire