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

Primary Purpose

Gingival Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flossing technique
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Inflammation focused on measuring flossing

Eligibility Criteria

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

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.

Sites / Locations

  • Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Subjects instructed on flossing technique.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
January 2, 2020
Last Updated
January 3, 2020
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT04218994
Brief Title
The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
Official Title
The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 2, 2018 (Actual)
Study Completion Date
December 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation
Keywords
flossing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects instructed on flossing technique.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
No instructions for flossing provided. Subjects asked to continue their normal oral hygiene care.
Intervention Type
Other
Intervention Name(s)
Flossing technique
Intervention Description
Subjects instructed on flossing technique
Primary Outcome Measure Information:
Title
Gingival Bleeding Index
Description
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).
Time Frame
Change from Baseline to 8-Week Visit
Secondary Outcome Measure Information:
Title
Modified O'Leary Plaque Score Index
Description
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).
Time Frame
Change from Baseline to 8-Week Visit
Title
Gingival Bleeding Index
Description
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).
Time Frame
Change from Baseline to 2-Week Visit
Title
Gingival Bleeding Index
Description
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).
Time Frame
Change from Baseline to 4-Week Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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

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