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

Self Cleaning Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601585
• Other study ID #: self-cleaning
• Status: Completed
• Phase: Early Phase 1
• Start date: March 15, 2018
• Est. completion date: June 19, 2018

Study information

• Verified date: July 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 19, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Self Cleaning

Intervention

Device:
• Comparison of dental biofilm removal.
Comparison of the use of 4 methods for dental biofilm removal

Locations

Country	Name	City	State
Brazil	Periodontics Clinic, Department of Dentistry	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index	Comparison of the Quigley-Hein plaque index between the following groups: rolly brush, chewing gum, a, apple, brush.	3 months