Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

Sponsor
Tufts University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04427397
Collaborator
Philips Healthcare (Industry)
38
1
2
18.1
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sulcular Bristle Tip Technique (SBTT)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 29, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in bleeding on probing (BOP) [Baseline through study completion, an average of 4 months]

    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.

Secondary Outcome Measures

  1. Effectiveness of professional cleaning [Baseline and 4 months]

    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

  2. Change in plaque [Baseline and 4 months]

    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.

  3. Evaluating deformation of toothbrush bristles [Baseline through study completion, an average of 4 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tufts University School of Dental Medicine Boston Massachusetts United States 02111

Sponsors and Collaborators

  • Tufts University
  • Philips Healthcare

Investigators

  • Principal Investigator: Livia Valverde, DMD, Tufts University School of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Livia Valverde, Assistant Professor, Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier:
NCT04427397
Other Study ID Numbers:
  • STUDY00000432
First Posted:
Jun 11, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Livia Valverde, Assistant Professor, Tufts University School of Dental Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022