The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial

NCT04218994 | Completed

• 1 other identifier: 12560
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, half of the participants will be asked to floss as normal, while the other half will receive professional instructions on flossing from a dentist. The investigators want to see if the participants who have professional flossing instructions are able to remove plaque in between the teeth more effectively, and have less gum bleeding over time. The investigators also want to see if participants who receive professional flossing instructions get better at the technique over time, and if they can match the dentist's skill by the end of the study.

Conditions

Gingival Inflammation

Keywords

flossing

Outcome Measures

Primary Outcomes (1)

• Gingival Bleeding Index

  The examiner gently swiped the probe at the most apical portion of the gingival crevice from line angle to line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial (facial and lingual) and the distal (facial and lingual).

  Change from Baseline to 8-Week Visit

Secondary Outcomes (3)

• Modified O'Leary Plaque Score Index

  Change from Baseline to 8-Week Visit

• Gingival Bleeding Index

  Change from Baseline to 2-Week Visit

• Gingival Bleeding Index

  Change from Baseline to 4-Week Visit

Study Arms (2)

Group A

EXPERIMENTAL

Subjects instructed on flossing technique.

Other: Flossing technique

Group B

NO INTERVENTION

No instructions for flossing provided. Subjects asked to continue their normal oral hygiene care.

Interventions

Flossing technique OTHER

Subjects instructed on flossing technique

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Subjects must show \> 20% interproximal sites (mesial facial and mesial lingual and distal facial and distal lingual) with BoP. This includes mesial and distal sites next to edentulous areas.
• Subjects must have \> 24 natural teeth including teeth with crowns with margins confluent with the natural tooth as long as they do not violate the biologic width.
• Third molars will be excluded from study; unless the third molars are in the anatomical position of second molars. However, subjects with third molars present will be accepted into the study unless there are other factors that exclude them.
• Subjects must report having had a professional dental prophylaxis within four months of beginning the study.
• Subjects must be willing to floss daily and to be taught and use a specific technique of flossing.

You may not qualify if:

• Subjects who use tobacco products.
• Subjects with fixed or removable orthodontic appliances
• Subjects with splinted fixed prostheses.
• Subjects who are incapable of flossing their teeth
• Subjects with defective interproximal restorations or interproximal caries that are clinically evident and impacting gingival health.
• Subjects where malposed teeth preclude the use of floss
• Subjects with probing depth greater than or equal to 5mm.
• Subjects who are pregnant (self-reported) due to the greater bleeding tendency due to the hormonal changes.
• Subjects with a systemic disease that affects the gingiva or are taking medications of which affect the gingiva.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: January 8, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (1)