A clinical study to assess the efficacy of a new interactive toothbrush in the reduction of gingivitis and dental plaque
- Conditions
- Mild to moderate gingivitisOral HealthGingivitis and periodontal diseases
- Registration Number
- ISRCTN77960012
- Lead Sponsor
- Procter & Gamble (United States)
- Brief Summary
2021 Poster results in https://iadr.abstractarchives.com/abstract/21iags-3571389/efficacy-of-an-electric-toothbrushsensitive-brush-head-for-gingivitis-reduction (added 12/01/2022) 2021 Poster results in https://iadr.abstractarchives.com/abstract/21iags-3568190/plaque-reduction-of-novel-electric-toothbrush-with-sensitive-brush-head (added 12/01/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Give written informed consent prior to study participation and be given a signed copy of their informed consent form
2. Be at least 18 years of age and typically use a manual toothbrush
3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history
4. Possess a minimum of 16 natural teeth with facial and lingual scorable surfaces
5. Have a Baseline whole mouth mean MGI score of at least 1.75 but not more than 2.5
6. Have a Baseline whole mouth pre-brushing RMNPI score of greater than 0.5
7. Have at least 20 but not more than 90 bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline whole mouth mean
8. Agree not to participate in any other oral care study for the duration of this study
9. Agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study
10. Agree to refrain from using any non-study oral hygiene products for the study duration
11. Agree to return for all their scheduled visits and to follow all study procedures
12. Refrain from brushing their teeth or from performing any other oral hygiene procedure anytime within the 12 hours prior to Baseline Visit and agree to follow these same restrictions prior to all visits
13. Refrain from medicated lozenges, breath mints, eating, drinking*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *(Allowed small sips of water up until 45 minutes prior to their appointments)
1. A condition requiring the need for antibiotic premedication prior to dental procedures
2. Severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession
3. Teeth that are grossly carious, fully crowned, or extensively restored
4. Active treatment for the following conditions: periodontitis, cancer, or a seizure disorder
5. Report to be nursing or pregnant, or intend to become pregnant any time during the course of this study
6. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks
7. Have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device
8. Oral/gum surgery within the previous 2 months
9. A disease or condition that could possibly interfere with examination/procedures or with the subject’s safe completion of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Gingival inflammation and bleeding measured by Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) at baseline, week 1, and week 12<br> 2. Dental plaque measured by Rustogi Modification of the Navy Plaque Index (RMNPI) at baseline (pre- and post-brushing), week 1, and week 12 (both pre-brushing only)<br>
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures