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

NCT03624647 | Completed

• 1 other identifier: 2018030
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Dental Plaque

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Power toothbrush

EXPERIMENTAL

Device: Power toothbrush

Manual toothbrush

PLACEBO COMPARATOR

Device: Manual toothbrush

Interventions

Power toothbrush DEVICE

Experimental power toothbrush

Power toothbrush

Manual toothbrush DEVICE

Marketed manual toothbrush

Manual toothbrush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

All Sum Research Ltd.

Mississauga, Ontario, L4W0C2, Canada

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 10, 2018
• Study Start: July 9, 2018
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

CA (1)