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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Inflammation
• Intervention / Treatment: Other: Flossing technique

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects instructed on flossing technique.	Other: Flossing technique; Subjects instructed on flossing technique
No Intervention: Group B; No instructions for flossing provided. Subjects asked to continue their normal oral hygiene care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified O'Leary Plaque Score Index	The subjects chewed a Sunstar Butler GUM™ disclosing tablet, and once dissolved in the saliva they swished it in their mouth for 30 seconds. Then they expectorated and rinsed their mouth with water. A plaque index (Modified O'Leary Plaque Score Index Chart) was recorded in which the all teeth surface are stained using a plaque disclosing dye. Plaque was marked as whether present or absent interproximally only for each tooth (buccal and lingual surfaces).	Change from Baseline to 8-Week Visit
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 2-Week Visit
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 4-Week Visit

Collaborators and Investigators

• Sponsor: Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): December 2, 2018
• Study Completion (Actual): December 2, 2018

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: flossing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Hemorrhage; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Inflammation; Gingivitis; Gingival Hemorrhage
• Other Study ID Numbers: 12560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No