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

• ClinicalTrials.gov Identifier: NCT03601585
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Olga Flecha, Federal University of São Paulo

Study Description

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

Condition or disease	Intervention/treatment	Phase
Self Cleaning	Device: Comparison of dental biofilm removal.	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Device Feasibility
• Official Title: Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal: A Randomized, Double Masked Clinical Trial
• Actual Study Start Date: March 15, 2018
• Actual Primary Completion Date: June 19, 2018
• Actual Study Completion Date: June 19, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Brazil

Periodontics Clinic, Department of Dentistry

Diamantina, Minas Gerais, Brazil, 39100000

Sponsors and Collaborators

Federal University of São Paulo

More Information

• Responsible Party: Olga Flecha, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT03601585
• Other Study ID Numbers: self-cleaning
• First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No