Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tooth brush without nylon bristles
Tooth brush with soft nylon bristles
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- receive regular periodontal treatment at the Western University of Health Sciences Dental Center
- have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths
Exclusion Criteria:
- unable to provide consent
- had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
- acute pain or infection
- caries near the gingival margin
- restorations covering the gingival recession defect
- presence of Miller Class III or IV defects
- severe or aggressive periodontitis
- missing more than one anterior tooth
- severe malocclusion
- presence of occlusal trauma requiring more than limited adjustment
- Tobacco use
- ongoing or planned orthodontic therapy
- oral piercings
- history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
- preferred use of an electric tooth brush over a manual brush
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bristle-less brush
Soft bristle brush
Arm Description
Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily
Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily
Outcomes
Primary Outcome Measures
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
Secondary Outcome Measures
Plaque level
Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
Gingival bleeding on probing
% bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.
Full Information
NCT ID
NCT02951065
First Posted
October 27, 2016
Last Updated
May 8, 2017
Sponsor
Western University of Health Sciences
Collaborators
Peri-Swab, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02951065
Brief Title
Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
Official Title
A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
April 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University of Health Sciences
Collaborators
Peri-Swab, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.
Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.
Detailed Description
Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.
Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bristle-less brush
Arm Type
Experimental
Arm Description
Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily
Arm Title
Soft bristle brush
Arm Type
Active Comparator
Arm Description
Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily
Intervention Type
Other
Intervention Name(s)
Tooth brush without nylon bristles
Other Intervention Name(s)
PeriClean Toothbrush
Intervention Description
Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Intervention Type
Other
Intervention Name(s)
Tooth brush with soft nylon bristles
Other Intervention Name(s)
Oral B soft brush
Intervention Description
Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Primary Outcome Measure Information:
Title
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Description
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
Time Frame
About 1 year
Secondary Outcome Measure Information:
Title
Plaque level
Description
Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
Time Frame
About 1 year
Title
Gingival bleeding on probing
Description
% bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
Time Frame
About 1 year
Title
Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
Description
This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.
Time Frame
About 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
receive regular periodontal treatment at the Western University of Health Sciences Dental Center
have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths
Exclusion Criteria:
unable to provide consent
had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
acute pain or infection
caries near the gingival margin
restorations covering the gingival recession defect
presence of Miller Class III or IV defects
severe or aggressive periodontitis
missing more than one anterior tooth
severe malocclusion
presence of occlusal trauma requiring more than limited adjustment
Tobacco use
ongoing or planned orthodontic therapy
oral piercings
history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
preferred use of an electric tooth brush over a manual brush
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
We'll reach out to this number within 24 hrs