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

Indiana University

Status

Completed

Conditions

Supragingival Plaque

Gingivitis

Treatments

Device: Brushing and Flossing of teeth

Other: Brushing Only

Study type

Interventional

Funder types

Other

Identifiers

NCT06515483

22752

Details and patient eligibility

About

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.

Full 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 representative will sign and date the consent to confirm that the consent process was completed before initiating any study procedures. The subject will be given a copy of the signed consent. The study dentist will collect and review information related to the subject's demographic, medical, and concomitant medications. The subject will have a hard and soft tissue exam, as well as a clinical examination of the gums and dental plaque present using the Lobene modified gingival index for gingivitis assessment, the marginal bleeding on probing index and the Turesky modification of the Quigley and Hain plaque index.

A total of 64 subjects who meet the study criteria will be enrolled and randomized into two groups. 32 subjects will be assigned to the control group (Brushing twice a day only and no flossing) and 32 to the experimental group (Brushing and Flossing with the stretchable loop floss twice daily). Each subject will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group will brush their teeth at least twice a day only, and subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day. To assess compliance, each subject will be asked to fill out a diary every time they brush/floss. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.

All clinical examinations will be performed by examiners who will be blind to the subject's oral hygiene procedures.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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