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

Description

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

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Study Overview

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Study Details

Study overview

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.

Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days

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

Condition
Gingivitis
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female and Male subjects between 18 to 65 years old
  • * Willing to read and sign the IRB-approved informed consent
  • * Healthy, as determined by pertinent medical history at the examiner dentist's discretion
  • * A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
  • * Mild to moderate plaque and gingivitis GI of 1.75 or greater (The Lobene-modified gingival index score) calculation made based on a whole mouth score
  • * PLI of 1.95 or greater (Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score
  • * Be willing to comply with study visits and requirements
  • * Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study
  • * Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect
  • * Orthodontic appliances appliances (except for fixed lingual retainers, teeth will be excluded from the teeth count) or any removable prosthesis
  • * Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
  • * Taking antibiotics two weeks before baseline procedures and throughout the study
  • * Need for antibiotic prophylaxis prior to dental procedures
  • * Use of daily anti-inflammatory drugs (NSAID, TNF- AB, others) within 30 days before baseline
  • * Pregnant, wanting to get pregnant, or breast-feeding female
  • * Acute Temporomandibular Disorders (TMD)
  • * Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study entry
  • * Subject who has previously been randomized in this study
  • * Self-reported allergy to disclosing solution ingredients (red dye #28)
  • * An employee of the study site directly involved with the study

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Indiana University,

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

Study Record Dates

2025-01-30