Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

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Tufts University

Status

Terminated

Conditions

Gum Bleed

Treatments

Other: Sulcular Bristle Tip Technique (SBTT)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04427397
STUDY00000432

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups

Sulcular Bristle Tip Technique (SBTT)
Experimental group
Description:
This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT).
Treatment:
Other: Sulcular Bristle Tip Technique (SBTT)
User manual of the electric toothbrush (DFU)
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Livia Valverde, DMD

Data sourced from clinicaltrials.gov

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