Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

Not Applicable

Terminated

• Conditions: Gum Bleed
• Interventions: Other: Sulcular Bristle Tip Technique (SBTT)

• Registration Number: NCT04427397
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2021-06-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulcular Bristle Tip Technique (SBTT)	Sulcular Bristle Tip Technique (SBTT)	This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States