NCT03876353

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

February 26, 2019

Last Update Submit

March 13, 2019

Conditions

Oral Plaque Biofilm

Outcome Measures

Primary Outcomes (1)

  • measure removal of oral plaque biofilm

    Evaluate the correlation between flossing and oral plaque biofilm formation

    15 minutes

Study Arms (2)

Left Side

OTHER

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

Right Side

OTHER

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

Interventions

FlossOTHER

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

Left SideRight Side

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any persons 18 years of age and able to consent

You may not qualify if:

  • A person being edentulous or who have teeth that do not contact Allergy to erythrosine dye (red #3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universsity of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Interventions

Dental Devices, Home Care

Intervention Hierarchy (Ancestors)

Dental EquipmentDentistryOral HygienePreventive DentistryEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 15, 2019

Study Start

January 7, 2019

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)