Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques
Primary Purpose
Gingival Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Instructed Brushing Method
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Inflammation
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age
- Subjects must have at least 20 teeth
- Subjects must have had a professional dental prophylaxis done in the 3 months prior to the beginning of the study
- Subjects exhibiting 10% or greater BoP at the baseline examination
Exclusion Criteria:
- Subjects wearing fixed orthodontic appliances (including lingual retainers or Invisalign®)
- Subjects who smoke (=more than 0 cigarettes a day)
- Subjects who received antibiotic treatment during the month prior to the beginning of the study
- Subjects who have cervical probing depth (PD) greater than 3mm
- Subjects diagnosed with periodontal disease at any site as defined bleeding on probing with cervical probing depths greater than 3 mm and loss of cervical attachment.
- Subjects who are currently pregnant (self-report).
Sites / Locations
- Tufts University School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stationary Bristle Technique (SBT)
Non-Stationary Bristle Technique (NSBT)
Arm Description
Instructed brushing method. Participants are asked to brush twice daily, for 2 minutes at a time, following instructions for the Stationary Bristle Technique.
The control group will be asked to brush twice daily, for 2 minutes at a time, following their normal toothbrushing technique.
Outcomes
Primary Outcome Measures
Change in Gingival Inflammation
Measured by the percentage of sites with BoP. The percentage of sites with BoP at each time point will be calculated by group
Secondary Outcome Measures
Toothbrush Bristle Deformation
Toothbrush bristle deformation will be measured at 4 weeks, 12 weeks, and 16 weeks of brushing with SBT or NSBT. The mean and standard deviation of the deformation measurements (length and width) will be calculated at each time point for each group.
Change in BoP
The secondary evaluation of BoP will be at the 12 and 16 week time-point.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03158350
Brief Title
Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques
Official Title
A Tooth Brushing Technique That Reduces Gingival Inflammation and Toothbrush Deformation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Toothbrush plaque removal, along with interproximal flossing, helps to maintain the oral cavity free from periodontal diseases and dental caries. Although techniques such as the Bass Technique (BT), the Modified Bass Technique (MBT) and the Modified Stillman Technique (MST) are taught to dental students, dental hygiene students, and dental assistants, there is little evidence to discern which technique is more effective in reducing or preventing gingival inflammation.
At Tufts University School of Dental Medicine (TUSDM), a modification of the Bass intrasulcular technique is advocated to many students. We call this modification of the Bass technique a Stationary Bristle Technique (SBT), which is an intrasulcular technique that maintains the toothbrush bristle ends essentially stationary on the tooth cervically and in the gingival crevice.
In this study, half of the participants were taught the Stationary Bristle Technique Group, while the other half were not be provided with instructions, but asked to brush as normal (non-interventional group) throughout the duration of the study.
Detailed Description
This is a double-armed, randomized clinical trial. The primary aim of this study is to compare whether a Stationary Brushing Technique (SBT) is more effective in the reduction of gingival inflammation than permitting people to brush the way they normally do without instruction (Non-Stationary Brushing Technique).
Gingival inflammation is evidenced by the percentage (%) sites with Bleeding on Probing (BoP). The primary time-point will be at 4 weeks.
The amount of toothbrush bristle deformation at 4 weeks, 12, and 16 weeks of brushing with a SBT and with a NSBT will also be evaluated. 3. The secondary evaluation of BoP will be at the 12 and 16 week time-point.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stationary Bristle Technique (SBT)
Arm Type
Experimental
Arm Description
Instructed brushing method. Participants are asked to brush twice daily, for 2 minutes at a time, following instructions for the Stationary Bristle Technique.
Arm Title
Non-Stationary Bristle Technique (NSBT)
Arm Type
No Intervention
Arm Description
The control group will be asked to brush twice daily, for 2 minutes at a time, following their normal toothbrushing technique.
Intervention Type
Other
Intervention Name(s)
Instructed Brushing Method
Intervention Description
Stationary Bristle Technique
Primary Outcome Measure Information:
Title
Change in Gingival Inflammation
Description
Measured by the percentage of sites with BoP. The percentage of sites with BoP at each time point will be calculated by group
Time Frame
From Baseline up to 4 weeks
Secondary Outcome Measure Information:
Title
Toothbrush Bristle Deformation
Description
Toothbrush bristle deformation will be measured at 4 weeks, 12 weeks, and 16 weeks of brushing with SBT or NSBT. The mean and standard deviation of the deformation measurements (length and width) will be calculated at each time point for each group.
Time Frame
From baseling up to 16 weeks
Title
Change in BoP
Description
The secondary evaluation of BoP will be at the 12 and 16 week time-point.
Time Frame
From baseline up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 18 years of age
Subjects must have at least 20 teeth
Subjects must have had a professional dental prophylaxis done in the 3 months prior to the beginning of the study
Subjects exhibiting 10% or greater BoP at the baseline examination
Exclusion Criteria:
Subjects wearing fixed orthodontic appliances (including lingual retainers or Invisalign®)
Subjects who smoke (=more than 0 cigarettes a day)
Subjects who received antibiotic treatment during the month prior to the beginning of the study
Subjects who have cervical probing depth (PD) greater than 3mm
Subjects diagnosed with periodontal disease at any site as defined bleeding on probing with cervical probing depths greater than 3 mm and loss of cervical attachment.
Subjects who are currently pregnant (self-report).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Levi, Jr., DMD
Organizational Affiliation
TUSDM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques
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