Clinical trial NCT04427397: Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush
Official title: The Effects of Using the Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush in Reducing Bleeding on Probing and Plaque Removal: A Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gum Bleed
Keywords: sulcular bristle tip technique
SBTT
brushing
plaque
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2020-06-11
Enrollment: 25
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: In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. The study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Subjects must show \> 20% buccal/lingual cervical sites with bleeding on probing (BoP)
* Subjects must have \> 24 natural teeth excluding third molars
* Subjects must have had a professional dental prophylaxis within three months of beginning the study
* Subjects must be willing to brush with electric toothbrush twice daily.
* Subjects who are randomized into Group 1 must be willing to be taught and to demonstrate the SBTT
* Subjects who are randomized into Group 2 must be willing to follow the Sonicare DFU from Philips Oral Healthcare; however, will otherwise be uninstructed until after the study has been completed
* Subjects must be willing to refrain from any oral hygiene for at least 12-18 hours prior to each study follow-up visit.

Exclusion Criteria:

* Subjects who use tobacco products
* Subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes
* Subjects with fixed or removable orthodontic appliances
* Subjects whose restorations violate or potentially violate the biologic width.
* Subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva.
* Antibiotic treatment at the time of the initial examination or during the month prior
* Subjects with cervical probing depth \>3 mm
* Subjects with systemic diseases that affect the gingiva
* Subjects taking medications that affect the gingiva
* Subjects who cannot read/write/speak English

Primary outcomes:
measure: Change in bleeding on probing (BOP)
timeFrame: Baseline through study completion, an average of 4 months
Secondary outcomes:
measure: Effectiveness of professional cleaning
timeFrame: Baseline and 4 months
measure: Change in plaque
timeFrame: Baseline and 4 months
measure: Evaluating deformation of toothbrush bristles
timeFrame: Baseline through study completion, an average of 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Livia Valverde, DMD
role: PRINCIPAL_INVESTIGATOR
References: