Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-02 @ 3:44 PM
Study NCT ID:
NCT03158350
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
A Tooth Brushing Technique That Reduces Gingival Inflammation and Toothbrush Deformation
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: