N/A
Completed N=64
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
Gingivitis · Supragingival Plaque
Source: ClinicalTrials.gov NCT06515483 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Dental Plaque Assessment — 4.026; 3.947; 3.856; 3.892 Index — p=0.323
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 supragingival plaque removal between two groups, control (no-floss) and experimental (flossing with Floss Loops), during thirty (2 +/-) days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Plaque Assessment |
4.026; 3.947; 3.856; 3.892; -0.170; -0.055 | 0.323 |
| PRIMARY Gingivitis Assessment |
2.335; 2.257; 2.227; 2.312; -0.108; 0.055 | 0.270 |
| SECONDARY Bleeding on Marginal Probing (BOMP) |
25.18; 24.87; 17.41; 25.63; -7.77; 0.76 | 0.902 |
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06515483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.