Status:
COMPLETED
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
Lead Sponsor:
Indiana University
Conditions:
Gingivitis
Supragingival Plaque
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 suprag...
Detailed Description
At the screening/baseline visit, potential subjects will be given the IRB-approved informed consent form to read and ask questions. After the subject signs and dates the consent, the study representat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06515483
Start Date
October 15 2024
End Date
December 4 2024
Last Update
June 13 2025
Active Locations (1)
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1
Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
Indianapolis, Indiana, United States, 46202