Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

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

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.

Study Overview

• Status: Terminated
• Conditions: Gum Bleed
• Intervention / Treatment: Other: Sulcular Bristle Tip Technique (SBTT)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Livia Valverde, DMD; Phone Number: 617-636-6828; Email: Livia.Valverde@tufts.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulcular Bristle Tip Technique (SBTT); This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT).	Other: Sulcular Bristle Tip Technique (SBTT); Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice.
No Intervention: User manual of the electric toothbrush (DFU); This control group will be asked to read and use the instructions found in the user manual of the electric toothbrush (DFU). No formal instruction will be provided. The DFU accompany the electric toothbrush regardless of the subject's participation in the research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bleeding on probing (BOP)	To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.	Baseline through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of professional cleaning	To compare whether a dental professional's (DP) cleaning a subject's teeth using an electric toothbrush with the SBTT is more effective in removing cervical plaque than the patient self-cleaning using electric toothbrush with the SBTT at the initial visit and after four months	Baseline and 4 months
Change in plaque	To compare the plaque removal of each subject at the initial visit with their plaque removal after four months of using the SBTT. To compare the plaque removal of the DP at the initial visit with the DP's plaque removal at the fourth month visit.	Baseline and 4 months
Evaluating deformation of toothbrush bristles	To compare the deformation of toothbrush bristles when used by patients using the SBTT with an electric toothbrush with the deformation of the toothbrush bristles with patients using an electric toothbrush uninstructed and whether the deformation is associated with BoP in each group.	Baseline through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Livia Valverde, DMD, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: plaque; sulcular bristle tip technique; SBTT; brushing
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Gingival Hemorrhage
• Other Study ID Numbers: STUDY00000432

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No