A 4-week study to assess the efficacy of a new electric toothbrush to reduce dental plaque and gingival inflammatio

Not Applicable

Completed

• Conditions: Evidence of dental plaque and gingivitis; Oral Health

• Registration Number: ISRCTN13370721
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-13
• Study Completion: 2023-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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 exclusively 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 whole mouth pre-brushing RMNPI score of greater than 0.5 for Baseline exam
6. Have localized or generalized gingivitis with a range of 10% to 70% bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline exam
7. Agree not to participate in any other oral care study for the duration of this study
8. 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
9. Agree to refrain from using any non-study oral hygiene products for the study duration
10. Agree to return for all their scheduled visits and to follow all study procedures
11. 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;
12. Refrain from medicated lozenges, breath mints, eating, drinking*, chewing gum and using tobacco (of any kind) 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)

Exclusion Criteria

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. Self-reported pregnancy or nursing
4. Any carious lesions requiring restorative treatment
5. Suffer from diabetes
6. Active treatment for the following conditions: periodontitis, cancer, or a seizure disorder
7. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks
8. Taking anti-inflammatory or anti-coagulant medications any time within the previous 2 weeks
9. Have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted - oral/gum surgery within the previous 2 months
10. A disease or condition that could possibly interfere with examination/procedures or with the subject’s safe completion of this study (including allergies to dye)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of bleeding sites change from baseline at Week 4 measured by the Gingival Bleeding Index

Secondary Outcome Measures

Name	Time	Method
1. Whole mouth plaque change from baseline (pre-brushing) at Week 4. Plaque will be measured using the Rustogi Modification of the Navy Plaque Index (RMNPI)<br>2. Whole mouth plaque removal at Baseline (single brushing) measured as above<br>3. Gingivitis change from baseline at Week 4. Gingivitis will be measured using the Modified Gingival Index (MGI)