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

Gingival Inflammation Clinical Trial

Official title:

A Tooth Brushing Technique That Reduces Gingival Inflammation and Toothbrush Deformation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158350
• Other study ID #: 11724
• Status: Completed
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2019
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gingival Inflammation
• Gingivitis
• Inflammation

Intervention

Other:
• Instructed Brushing Method
Stationary Bristle Technique

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in BoP	The secondary evaluation of BoP will be at the 12 and 16 week time-point.	From baseline up to 16 weeks