University of New Mexico Dental Hygiene

Study Overview
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Brief Summary
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To evaluate the efficacy of flossing in the removal of oral plaque biofilm.

Detailed Description
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Flossing is universally recognized in the dental profession as a primary component of oral hygiene. Data supports the correlation between flossing and disease prevention by ways of reducing gingival bleeding, gingivitis, and dental caries.(1, 2) However, a recent AP publication (3) questioning the validity of flossing as an efficacious preventative method has warranted that oral healthcare professionals address certain underlying assumptions about the practice. Specifically, there is a clear gap in the number of clinical effectiveness trials that measure the ability of flossing for the sole purpose of oral plaque biofilm removal. Such studies are urgently needed. At this moment we can only assume flossing's correlation with disease prevention also links flossing with effectively removing oral plaque biofilm. Due to the current research gaps, additional studies must be performed to address the needs highlighted by the absence of substantive research in this field. Our long term goal is to evaluate if flossing is an effective oral health aid in the removal of oral plaque biofilm. The overall objective of this application is to provide a consistent measurement to confirm whether flossing is an effective oral care technique in removing disease causing oral plaque biofilm . The rationale that underlies this proposal comes from the many professional associations, such as the American Dental Association, American Dental Hygienists' Association, and the U.S. Department of Health and Human Services, that endorse flossing as an effective home care routine in oral disease prevention. Many oral health professionals would argue that flossing is effective in plaque removal, as they have seen the results anecdotally year after year, yet it is clear that additional studies are needed to move what is known anecdotally to what is known scientifically.

Official Title
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Efficacy of Flossing in the Removal of Oral Plaque Biofilm

Conditions
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Oral Plaque Biofilm

Intervention / Treatment
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* Other: Floss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any persons 18 years of age and able to consent Exclusion Criteria: A person being edentulous or who have teeth that do not contact Allergy to erythrosine dye (red #3)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Left Side<br>Each participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque | Other: Floss<br>* All participants will have half of their mouth flossed. Each participant will act as their own control.<br>|
| Other: Right Side<br>Each participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque | Other: Floss<br>* All participants will have half of their mouth flossed. Each participant will act as their own control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure removal of oral plaque biofilm | Evaluate the correlation between flossing and oral plaque biofilm formation | 15 minutes |