Effectiveness of the Use of Dental Floss

NCT04909840 | Completed

• 1 other identifier: 53831716.5.0000.5346
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Bacterial plaque-induced gingivitis is considered the most common oral disease in dentate individuals and the most frequent type of periodontal disease. Manual brushing is the most widely used method for mechanical plaque self-control and, consequently, prevention and treatment of gingivitis. The effectiveness of brushing, however, is questionable in interproximal areas. Thus, interdental cleaning is recognized as an essential part of maintaining gingival health and the most recommended interdental device is dental floss. However, there is weak scientific evidence available about the recommendation for daily flossing. The objective of this randomized blinded trial is to evaluate the efficacy and effectiveness of oral hygiene using soft toothbrush associated with dental floss versus soft toothbrush in maintaining the gingival condition in adults without loss of insertion. Seventy-six subjects with generalized gingivitis at proximal sites will be randomized into two experimental groups according to the use of dental floss: Manual toothbrushing group without the use of dental floss (without dental floss) and Group dental toothbrushing and dental flossing (dental floss). During a period of 8 weeks, the efficacy of the use of the toothbrush associated with the use of the dental floss will be evaluated. After this period, the baseline of the effectiveness study begins. After this period, the baseline of the effectiveness study begins. Participants will be followed up for another 12 months to evaluate the effectiveness of flossing. The parameters Index of Gingival Bleeding (GB) and Plaque Index (PI) will be evaluated at the baseline, 60, 120, 240 and 360 days. Descriptive analysis of GB and PI data will be performed using means, standard deviations and mean percentage of sites with different GB and PI scores. The differences in the means of GB and PI over time between groups and within the same group will be analyzed using the Poisson Multilevel Regression model. The main outcome will be the maintenance of the gingival condition. The difference in interventions will be compared using the chi-square test with significance level of 5%. Adults with less than 15% of sites with gingival bleeding will be considered healthy.

Conditions

Gingivitis

Keywords

gingival inflammation; periodontal disease; dental plaque; dental floss

Outcome Measures

Primary Outcomes (1)

• gingival condition

  The gingival condition will be assessed through the Gingival Index (GI) (Löe, 1967)

  14 months

Secondary Outcomes (1)

• Oral Health-related Quality of Life

  14 months

Study Arms (2)

dental floss

EXPERIMENTAL

Instructions of oral hygiene with toothbrush plus dental floss

Other: Instructions oral hygiene with toothbrush plus dental floss

without dental floss

ACTIVE COMPARATOR

Individuals who will use only toothbrush

Other: Instructions oral hygiene with toothbrush only

Interventions

Instructions oral hygiene with toothbrush plus dental floss OTHER

Instructions of oral hygiene with toothbrush plus dental floss

dental floss

Instructions oral hygiene with toothbrush only OTHER

Instructions only with toothbrush

without dental floss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with at least 18 years of age, without loss of proximal clinical insertion, with papilla completely filling the interdental space and with at least 24 teeth will be eligible.
• Individuals should present gingivitis in 15% of the proximal sites (gingival marginal bleeding, gingival index score 2, LÖE, 1967). Distal sites of the posterior teeth will not be counted in the analysis because they are not areas of flossing.

You may not qualify if:

• Dental students, individuals with xerostomia, pregnant women, diabetics, smokers, patients with orthodontic appliances and/or containment, individuals requiring antimicrobial prophylaxis to perform oral exams; who have used antibiotics/anti-inflammatories for the last three months and who have psychomotor disorders.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Carlos Heitor Cunha Moreira

Santa Maria, Rio Grande do Sul, 97015-372, Brazil

Location

Related Publications (2)

• Reiniger APP, Cr Tavares R, Ortigara GB, Tatsch KF, Uliana JC, Wikesjo UM, Moreira CHC, Kantorski KZ. Effectiveness of dental floss in the management of gingival health: A 6-month follow-up of a randomized controlled clinical trial. Clin Oral Investig. 2024 May 16;28(6):319. doi: 10.1007/s00784-024-05693-4.

  PMID: 38750375 DERIVED

• 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.

  PMID: 35451656 DERIVED

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Dental Plaque

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: June 2, 2021
• Study Start: June 4, 2018
• Primary Completion: September 4, 2020
• Study Completion: December 4, 2020
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)