Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal

Early Phase 1

Completed

• Conditions: Self Cleaning
• Interventions: Device: Comparison of dental biofilm removal.

• Registration Number: NCT03601585
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The objective of this study was to evaluate the efficacy of three methods for removal of dental biofilm when compared to dental toothbrushing control. Twenty patients were diagnosed and randomized into four groups according to the method tested: 1) apple 2) Rolly Brush 3) chewing gum and 4) brushing control. Subjects were evaluated four times according to the method used. All were evaluated before performing any method and after using each of the four methods separately. The patient's evaluation interval was 24 hours between the use of the methods. In the first stage, they underwent a clinical examination in which the needs of supragingival scraping or definitive restorations and prophylaxis were detected. After this step, all methods of oral hygiene and the consumption of fibrous foods and chewing gum were suspended for twenty-four hours. In the second stage, with a minimum of twenty-four hours after the first, volunteers received approximately 10 ml of basic fucsin to perform a mouthwash. The dental examination was then carried out for measurement on each dental surface and the plaque index was recorded on each surface. In the latter, four evaluations were performed with at least a 24-hour interval until the patients used the four methods

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Primary Completion: 2018-06-19
• Study Completion: 2018-06-19
• Status Verified: 2018-07
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Good periodontal health
• Minimum of eight occlusal surfaces of premolars and molars hygienic

Exclusion Criteria

• Less than eight occlusal surfaces
• Use of orthodontic appliance
• Use of dental prosthesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rolly Brush	Comparison of dental biofilm removal.	Chew for 1 minute
Chewing gum	Comparison of dental biofilm removal.	Chew for 1 minute
Apple	Comparison of dental biofilm removal.	Chew for 1 minute
Brush	Comparison of dental biofilm removal.	brush for 1 minute

Primary Outcome Measures

Name	Time	Method
Plaque index	3 months	Comparison of the Quigley-Hein plaque index between the following groups: rolly brush, chewing gum, a, apple, brush.

Trial Locations

Locations (1)

Periodontics Clinic, Department of Dentistry; 🇧🇷 Diamantina, Minas Gerais, Brazil