Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques

A Tooth Brushing Technique That Reduces Gingival Inflammation and Toothbrush Deformation

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.

Study Overview

• Status: Completed
• Conditions: Gingival Inflammation
• Intervention / Treatment: Other: Instructed Brushing Method

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stationary Bristle Technique (SBT); Instructed brushing method. Participants are asked to brush twice daily, for 2 minutes at a time, following instructions for the Stationary Bristle Technique.	Other: Instructed Brushing Method; Stationary Bristle Technique
No Intervention: Non-Stationary Bristle Technique (NSBT); The control group will be asked to brush twice daily, for 2 minutes at a time, following their normal toothbrushing technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From Baseline up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseling up to 16 weeks
Change in BoP	The secondary evaluation of BoP will be at the 12 and 16 week time-point.	From baseline up to 16 weeks

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Paul A Levi, Jr., DMD, TUSDM

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis
• Other Study ID Numbers: 11724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No