Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

Gum Bleed Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04427397
• Other study ID #: STUDY00000432
• Status: Terminated
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2024
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Hemorrhage
• Gum Bleed

Intervention

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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through study completion, an average of 4 months
Secondary	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	Baseline and 4 months
Secondary	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.	Baseline and 4 months
Secondary	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.	Baseline through study completion, an average of 4 months