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Effectiveness of the Use of Dental Floss

NCT04909840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-05-18

No results posted yet for this study

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

Interventions

OTHER

Instructions oral hygiene with toothbrush plus dental floss

Instructions of oral hygiene with toothbrush plus dental floss

OTHER

Instructions oral hygiene with toothbrush only

Instructions only with toothbrush

Sponsors & Collaborators

  • Universidade Federal de Santa Maria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2020-09-04
Completion
2020-12-04

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909840 on ClinicalTrials.gov