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

Study Overview
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Brief Summary
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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

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

Conditions
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Self Cleaning

Intervention / Treatment
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* Device: Comparison of dental biofilm removal.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |