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Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

Primary Purpose

Gum Bleed

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sulcular Bristle Tip Technique (SBTT)

About this trial

This is an interventional prevention trial for Gum Bleed focused on measuring sulcular bristle tip technique, SBTT, brushing, plaque

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Tufts University School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sulcular Bristle Tip Technique (SBTT)

User manual of the electric toothbrush (DFU)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

Full Information

NCT ID

NCT04427397

First Posted

June 5, 2020

Last Updated

March 9, 2022

Sponsor

Tufts University

Collaborators

Philips Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT04427397

Brief Title

Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 29, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

Collaborators

Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gum Bleed

Keywords

sulcular bristle tip technique, SBTT, brushing, plaque

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sulcular Bristle Tip Technique (SBTT)

Arm Type

Experimental

Arm Description

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

Arm Title

User manual of the electric toothbrush (DFU)

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Sulcular Bristle Tip Technique (SBTT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in bleeding on probing (BOP)

Description

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.

Time Frame

Baseline through study completion, an average of 4 months

Secondary Outcome Measure Information:

Title

Effectiveness of professional cleaning

Description

Time Frame

Baseline and 4 months

Title

Change in plaque

Description

Time Frame

Baseline and 4 months

Title

Evaluating deformation of toothbrush bristles

Description

Time Frame

Baseline through study completion, an average of 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Livia Valverde, DMD

Phone

617-636-6828

Livia.Valverde@tufts.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Livia Valverde, DMD

Organizational Affiliation

Tufts University School of Dental Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts University School of Dental Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Livia Valverde, DMD

Livia.Valverde@tufts.edu

12. IPD Sharing Statement

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Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

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