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

An 8-Week Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush in the Reduction of Gingivitis and Plaque

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Dental Plaque
• Intervention / Treatment: Device: Power toothbrush; Device: Manual toothbrush

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W0C2
      • All Sum Research Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Power toothbrush	Device: Power toothbrush; Experimental power toothbrush
PLACEBO_COMPARATOR: Manual toothbrush	Device: Manual toothbrush; Marketed manual toothbrush

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ACTUAL): September 14, 2018
• Study Completion (ACTUAL): September 14, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque
• Other Study ID Numbers: 2018030

Drug and device information, study documents

• 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