Clinical trial NCT03158350: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Inflammation
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in Gingival Inflammation
timeFrame: From Baseline up to 4 weeks
Secondary outcomes:
measure: Toothbrush Bristle Deformation
timeFrame: From baseling up to 16 weeks
measure: Change in BoP
timeFrame: From baseline up to 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: TUSDM
name: Paul A Levi, Jr., DMD
role: PRINCIPAL_INVESTIGATOR
References: