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

NCT ID: NCT03158350

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-03
• Study Completion Date: 2016-03-31

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.

Conditions

Gingival Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Instructed Brushing Method

Intervention Type: OTHER

Stationary Bristle Technique

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Instructed Brushing Method

Stationary Bristle Technique

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A Levi, Jr., DMD

Role: PRINCIPAL_INVESTIGATOR

TUSDM

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11724

Identifier Type: -

Identifier Source: org_study_id