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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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03601585
Enrollment
20
Registered
2018-07-26
Start date
2018-03-15
Completion date
2018-06-19
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Cleaning

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

Interventions

DEVICEComparison of dental biofilm removal.

Comparison of the use of 4 methods for dental biofilm removal

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plaque index3 monthsComparison of the Quigley-Hein plaque index between the following groups: rolly brush, chewing gum, a, apple, brush.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026