University of New Mexico Dental Hygiene

NCT ID: NCT03876353

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-02-11

Brief Summary

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

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.

Conditions

Oral Plaque Biofilm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Floss

Intervention Type: OTHER

All participants will have half of their mouth flossed. Each participant will act as their own control.

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

Group Type: OTHER

Floss

Intervention Type: OTHER

All participants will have half of their mouth flossed. Each participant will act as their own control.

Interventions

Floss

All participants will have half of their mouth flossed. Each participant will act as their own control.

Intervention Type: OTHER

Eligibility Criteria

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)

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

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Lindsey Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universsity of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

17-419

Identifier Type: -

Identifier Source: org_study_id