A clinical study to assess the efficacy of a new oral hygiene system in the reduction of gingivitis and dental plaque

Not Applicable

Completed

• Conditions: Oral mild to moderate gingivitis; Oral Health

• Registration Number: ISRCTN99297838
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

2021 Results article in https://www.aegisdentalnetwork.com/cced/2021/10/anti-gingivitis-and-anti-plaque-efficacy-of-an-oral-hygiene-system-results-from-a-12-week-randomized-controlled-trial?hq_e=el&hq_m=6388927&hq_l=61&hq_v=d6ae34473b (added 18/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Study Completion: 2020-06-12
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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 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. Possess a smartphone which runs Android 7.0 to 10.0, or an iPhone that runs on iOS 11.0 to 13.0 and agree to download a toothbrushing app from the manufacturer of the assigned brush. The mobile device must support Bluetooth 4.2 (or higher)/Bluetooth Smart
6. Have a Baseline whole mouth mean MGI score of at least 1.75 but not more than 2.5
7. Have a Baseline whole mouth pre-brushing RMNPI score of greater than 0.5
8. 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
9. Agree not to participate in any other oral care study for the duration of this study
10. 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
11. Agree to refrain from using any non-study oral hygiene products for the study duration
12. Agree to return for all their scheduled visits and to follow all study procedures
13. 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
14. 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.)

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. 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 two months
9. Any 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