Clinical trial NCT06515483: Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
Official title: Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Supragingival Plaque
Keywords: Dental floss, gingivitis, plaque
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A sufficient number of subjects will be screened to participate, and 64 will be randomized. We intend to randomize a nearly equal number of female and male subjects. A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned according to appearance at the study site. Subjects who meet all inclusion and exclusion criteria will be randomized into the study. Block randomization will be used to assign subjects to one of the two sequences: control regiment or experimental regimen. Randomization will be stratified by gender. Randomization numbers will be assigned using randomization schedules provided by the IU Department of Biostatistics and Health Data Science statistician.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Dental Plaque Assessment
timeFrame: Baseline and 30 days examination
measure: Gingivitis Assessment
timeFrame: Baseline and 30 days examination
Secondary outcomes:
measure: Bleeding on Marginal Probing (BOMP)
timeFrame: Baseline and 30 days examination
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
state: Indiana
Study officials:
affiliation: Indiana University School of dentistry, Oral Health Research Institute
name: Ana G Gossweiler, DDS/MSD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.