COMPLETED

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

Conditions

Gingivitis Supragingival Plaque Dental floss, gingivitis, plaque

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-15

Study Completion:2024-12-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06515483

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Ana G Gossweiler, DDS/MSD

PRINCIPAL_INVESTIGATOR

Indiana University School of dentistry, Oral Health Research Institute

Study Locations (Sites)

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

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2024-12-04

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2024-12-04

Terms related to this study

Keywords Provided by Researchers

Dental floss, gingivitis, plaque

Additional Relevant MeSH Terms

Gingivitis
Supragingival Plaque