Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

NCT ID: NCT04427397

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2022-12-31

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.

Conditions

Gum Bleed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sulcular Bristle Tip Technique (SBTT)

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

Group Type: EXPERIMENTAL

Sulcular Bristle Tip Technique (SBTT)

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Livia Valverde

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia Valverde, DMD

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00000432

Identifier Type: -

Identifier Source: org_study_id