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

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 15, 2024

Primary Completion Date

December 4, 2024

Study Completion Date

December 4, 2024

Conditions
GingivitisSupragingival 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.

Trial Locations (1)

46202

Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER

NCT06515483 - Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss | Biotech Hunter | Biotech Hunter