University of New Mexico Dental Hygiene (UNM)

Efficacy of Flossing in the Removal of Oral Plaque Biofilm

To evaluate the efficacy of flossing in the removal of oral plaque biofilm.

Study Overview

• Status: Completed
• Conditions: Oral Plaque Biofilm
• Intervention / Treatment: Other: Floss

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Universsity of New Mexico

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:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Left Side; 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; All participants will have half of their mouth flossed. Each participant will act as their own control.
Other: Right Side; 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; All participants will have half of their mouth flossed. Each participant will act as their own control.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): February 11, 2019
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17-419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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