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

NCT03158350 | Completed

• 1 other identifier: 11724
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Toothbrush Bristle Deformation

  From baseling up to 16 weeks

• Change in BoP

  From baseline up to 16 weeks

Study Arms (2)

Stationary Bristle Technique (SBT)

EXPERIMENTAL

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

Non-Stationary Bristle Technique (NSBT)

NO INTERVENTION

The control group will be asked to brush twice daily, for 2 minutes at a time, following their normal toothbrushing technique.

Interventions

Instructed Brushing Method OTHER

Stationary Bristle Technique

Stationary Bristle Technique (SBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Paul A Levi, Jr., DMD

  TUSDM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: August 3, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)