Evaluating a new stretchable dental floss for gingivitis and plaque control
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
NA · Indiana University · NCT06515483
This study is testing a new stretchable dental floss to see if it can help people with gingivitis and plaque better than just brushing their teeth alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06515483 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of Floss Loops stretchable dental floss in controlling gingivitis and removing supragingival plaque. It will involve 64 participants who will be randomly assigned to either a control group, which will only brush their teeth, or an experimental group, which will brush and floss with the stretchable floss. The study will last approximately 30 days, during which participants' oral health will be monitored through clinical examinations and plaque assessments. The trial is designed to provide insights into the benefits of using this innovative flossing method compared to standard brushing alone.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with mild to moderate gingivitis and plaque.
Not a fit: Patients with acute or chronic conditions that may affect their oral health or those with fewer than 20 natural teeth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oral hygiene practices and better management of gingivitis and plaque for patients.
How similar studies have performed: While there have been studies on dental floss efficacy, this specific approach using stretchable floss is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Ana G Gossweiler, DDS/MSD — Indiana University School of dentistry, Oral Health Research Institute
- Study coordinator: Lorena Galvez
- Email: logalvez@iu.edu
- Phone: (317) 274-8838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gingivitis, Supragingival Plaque, Dental floss, gingivitis, plaque