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

NCT ID: NCT06515483

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2024-12-04

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 supragingival plaque removal between two groups, control (no-floss) and experimental (flossing with Floss Loops), during thirty (2 +/-) days.

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 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.

Conditions

Gingivitis; Supragingival Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Brushing and Flossing

Group Type: EXPERIMENTAL

Brushing and Flossing of teeth

Intervention Type: DEVICE

32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. 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.

Arm 2

Brushing only

Group Type: PLACEBO_COMPARATOR

Brushing Only

Intervention Type: OTHER

32 subjects 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. 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.

Interventions

Brushing and Flossing of teeth

32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. 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.

Intervention Type: DEVICE

Brushing Only

32 subjects 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. 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Ana G. Gossweiler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana G Gossweiler, DDS/MSD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of dentistry, Oral Health Research Institute

Locations

Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street

Indianapolis, Indiana, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 29520910 (View on PubMed)

Shamsoddin E. Dental floss as an adjuvant of the toothbrush helps gingival health. Evid Based Dent. 2022 Sep;23(3):94-96. doi: 10.1038/s41432-022-0818-x. Epub 2022 Sep 23.

Reference Type: BACKGROUND

PMID: 36151277 (View on PubMed)

Alali AY, Al-Khabbaz A, Michael S, Swain MV. Frictional coefficient during flossing of teeth. Dent Mater. 2018 Dec;34(12):1727-1734. doi: 10.1016/j.dental.2018.09.002. Epub 2018 Sep 21.

Reference Type: BACKGROUND

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Huang Z, Broadbent JM, Choi JJE. Comparison of dental flosses - an investigation of subjective preference and mechanical properties. Biomater Investig Dent. 2023 Sep 22;10(1):2258919. doi: 10.1080/26415275.2023.2258919. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37753304 (View on PubMed)

Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4.

Reference Type: BACKGROUND

PMID: 11763934 (View on PubMed)

Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x.

Reference Type: BACKGROUND

PMID: 2709366 (View on PubMed)

Azcarate-Velazquez F, Garrido-Serrano R, Castillo-Dali G, Serrera-Figallo MA, Ganan-Calvo A, Torres-Lagares D. Effectiveness of flossing loops in the control of the gingival health. J Clin Exp Dent. 2017 Jun 1;9(6):e756-e761. doi: 10.4317/jced.53858. eCollection 2017 Jun.

Reference Type: BACKGROUND

PMID: 28638551 (View on PubMed)

Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

Reference Type: BACKGROUND

PMID: 5237684 (View on PubMed)

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

Reference Type: BACKGROUND

PMID: 5264376 (View on PubMed)

Londero AB, Reiniger APP, Tavares RCR, Ferreira CM, Wikesjo UME, Kantorski KZ, Moreira CHC. Efficacy of dental floss in the management of gingival health: a randomized controlled clinical trial. Clin Oral Investig. 2022 Aug;26(8):5273-5280. doi: 10.1007/s00784-022-04495-w. Epub 2022 Apr 22.

Reference Type: BACKGROUND

PMID: 35451656 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22752

Identifier Type: -

Identifier Source: org_study_id