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Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss

NCT06515483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-06-13

Study results available
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Summary

This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of Floss Loops stretchable floss for the control of gingivitis and supragingival plaque removal between two groups, control (no-floss) and experimental (flossing with Floss Loops), during thirty (2 +/-) days.

Conditions

  • Gingivitis
  • Supragingival Plaque

Interventions

DEVICE

Brushing and Flossing of teeth

32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day. To assess compliance, each subject will be asked to fill out a diary every time they brush/floss. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.

OTHER

Brushing Only

32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group will brush their teeth at least twice a day only. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Ana G Gossweiler, DDS/MSD · Indiana University School of dentistry, Oral Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2024-12-04
Completion
2024-12-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515483 on ClinicalTrials.gov