A Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush

• ClinicalTrials.gov Identifier: NCT03624647
• Recruitment Status: Completed
• First Posted: August 10, 2018
• Last Update Posted: September 27, 2018
• Sponsor: Procter and Gamble
• Information provided by (Responsible Party): Procter and Gamble

Study Description

Brief Summary:

The objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index.

Condition or disease	Intervention/treatment	Phase
Gingivitis; Dental Plaque	Device: Power toothbrush; Device: Manual toothbrush	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: An 8-Week Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush in the Reduction of Gingivitis and Plaque
• Actual Study Start Date: July 9, 2018
• Actual Primary Completion Date: September 14, 2018
• Actual Study Completion Date: September 14, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Power toothbrush	Device: Power toothbrush; Experimental power toothbrush
Placebo Comparator: Manual toothbrush	Device: Manual toothbrush; Marketed manual toothbrush

Outcome Measures

Primary Outcome Measures :

1. Modified Gingival Index [ Time Frame: Baseline ]
   MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
2. Modified Gingival Index [ Time Frame: Week 1 ]
   MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
3. Modified Gingival Index [ Time Frame: Week 8 ]
   MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
4. Rustogi Modification of the Navy Plaque Index [ Time Frame: Baseline ]
   RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
5. Rustogi Modification of the Navy Plaque Index [ Time Frame: Week 1 ]
   RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
6. Rustogi Modification of the Navy Plaque Index [ Time Frame: Week 8 ]
   RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• give written informed consent prior to study participation and be given a signed copy of their informed consent form
• be at least 18 years of age and typically use a manual toothbrush;
• be in good general health as determined by the investigator/designee based on a review/update of their medical history;
• possess a minimum of 16 natural teeth with facial and lingual scorable surfaces;
• have a Baseline pre-brushing MGI score of at least 1.75;
• have a Baseline pre-brushing RMNPI score of greater than 0.5;
• have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline pre-brushing;
• agree not to participate in any other oral care study for the duration of this study;
• 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;
• agree to refrain from using any non-study oral hygiene products for the study duration;
• agree to return for all their scheduled visits and to follow all study procedures;
• refrained from brushing their teeth or from performing any other oral hygiene procedures anytime within the 12 hours prior to their morning brushing and agree to follow these same restrictions prior to all visits except (the Week 1 p.m. visit);
• refrained from any oral hygiene, eating, drinking* (except small sips of water), chewing gum, and tobacco use for at least 3 hours but not more than 6 hours prior to this visit and agree to follow these same restrictions prior to all p.m. visits.

Exclusion Criteria:

• a condition requiring the need for antibiotic premedication prior to dental procedures;
• severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession;
• teeth that are grossly carious, fully crowned, or extensively restored;
• active treatment for the following conditions: periodontitis, cancer, or a seizure disorder;
• report to be nursing or pregnant, or intend to become pregnant any time during the course of this study;
• taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks;
• have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device;
• oral/gum surgery within the previous two months;
• a disease or condition that could possibly interfere with examination/procedures or with the subject's safe completion of this study.

Contacts and Locations

Locations

Canada, Ontario

All Sum Research Ltd.

Mississauga, Ontario, Canada, L4W0C2

Sponsors and Collaborators

Procter and Gamble

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT03624647
• Other Study ID Numbers: 2018030
• First Posted: August 10, 2018
• Last Update Posted: September 27, 2018
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Gingivitis; Dental Plaque; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases