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

NCT ID: NCT04218994

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-12-02

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.

Detailed Description

Primary Aim: To determine whether subjects instructed with a specific flossing technique have less gingival inflammation as evidenced by bleeding on probing (BoP) than subjects without flossing instructions.

Secondary Aim: To compare the effect of flossing by a dental professional with a patient's self-flossing following instruction in removing interdental plaque.

Secondary Aim: To compare the completeness of plaque removal by the subjects instructed during the initial visit (Group A [test]) with their completeness at the final (fourth) visit.

Secondary Aim: To compare the clinician's completeness of plaque removal at the fourth visit with the completeness of plaque removal by the subjects in both groups (Groups A [test] and B [control]). Each group will be analyzed separately. In Group A, a comparison of the plaque removal by the subjects and by the clinician will made with respect to the completeness at the first visit versus the final visit.

Conditions

Gingival Inflammation

Study Design

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

Study Groups

Group A

Subjects instructed on flossing technique.

Group Type: EXPERIMENTAL

Flossing technique

Intervention Type: OTHER

Subjects instructed on flossing technique

Group B

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Flossing technique

Subjects instructed on flossing technique

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Non-English speaking subjects, as study assessments and instructions will be in English only. There is no direct benefit to subjects for taking part in this study, therefore the exclusion of non-English speaking subjects is not an ethical concern.

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

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Paul Levi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

12560

Identifier Type: -

Identifier Source: org_study_id