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

Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal: A Randomized, Double Masked Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Self Cleaning
• Intervention / Treatment: Device: Comparison of dental biofilm removal.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Diamantina, Minas Gerais, Brazil, 39100000
      • Periodontics Clinic, Department of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rolly Brush; Chew for 1 minute	Device: Comparison of dental biofilm removal.; Comparison of the use of 4 methods for dental biofilm removal
Experimental: Chewing gum; Chew for 1 minute	Device: Comparison of dental biofilm removal.; Comparison of the use of 4 methods for dental biofilm removal
Experimental: Apple; Chew for 1 minute	Device: Comparison of dental biofilm removal.; Comparison of the use of 4 methods for dental biofilm removal
Active Comparator: Brush; brush for 1 minute	Device: Comparison of dental biofilm removal.; Comparison of the use of 4 methods for dental biofilm removal

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): June 19, 2018
• Study Completion (Actual): June 19, 2018

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: self-cleaning

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No