Back to resultsA Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush
Primary Purpose
Gingivitis, Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Power toothbrush
Manual toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility 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.
Sites / Locations
- All Sum Research Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Power toothbrush
Manual toothbrush
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03624647
Brief Title
A Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush
Official Title
An 8-Week Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush in the Reduction of Gingivitis and Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Dental Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Power toothbrush
Arm Type
Experimental
Arm Title
Manual toothbrush
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Power toothbrush
Intervention Description
Experimental power toothbrush
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
Marketed manual toothbrush
Primary Outcome Measure Information:
Title
Modified Gingival Index
Description
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame
Baseline
Title
Modified Gingival Index
Description
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame
Week 1
Title
Modified Gingival Index
Description
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame
Week 8
Title
Rustogi Modification of the Navy Plaque Index
Description
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame
Baseline
Title
Rustogi Modification of the Navy Plaque Index
Description
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame
Week 1
Title
Rustogi Modification of the Navy Plaque Index
Description
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
All Sum Research Ltd.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W0C2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Clinical Comparison of an Experimental Power Brush Compared to a Manual Toothbrush
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