NCT06515483Completed
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 17 Jul 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 4 Dec 2024
- Lead sponsor
- Indiana University
- NCT number
- NCT06515483
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 15 Oct 2024 to the primary completion date, 4 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
- Acute Temporomandibular Disorders (TMD)
- Self-reported allergy to disclosing solution ingredients (red dye #28)
Lab values
- Orthodontic appliances appliances (except for fixed lingual retainers, teeth will be excluded from the teeth count) or any removable prosthesis
Other
- Pregnant, wanting to get pregnant, or breast-feeding female
- An employee of the study site directly involved with the study
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.