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

NCT ID: NCT03601585

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2018-06-19

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

Detailed Description

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Conditions

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Self Cleaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Rolly Brush

Chew for 1 minute

Group Type EXPERIMENTAL

Comparison of dental biofilm removal.

Intervention Type DEVICE

Comparison of the use of 4 methods for dental biofilm removal

Chewing gum

Chew for 1 minute

Group Type EXPERIMENTAL

Comparison of dental biofilm removal.

Intervention Type DEVICE

Comparison of the use of 4 methods for dental biofilm removal

Apple

Chew for 1 minute

Group Type EXPERIMENTAL

Comparison of dental biofilm removal.

Intervention Type DEVICE

Comparison of the use of 4 methods for dental biofilm removal

Brush

brush for 1 minute

Group Type ACTIVE_COMPARATOR

Comparison of dental biofilm removal.

Intervention Type DEVICE

Comparison of the use of 4 methods for dental biofilm removal

Interventions

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Comparison of dental biofilm removal.

Comparison of the use of 4 methods for dental biofilm removal

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Olga Flecha

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Periodontics Clinic, Department of Dentistry

Diamantina, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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self-cleaning

Identifier Type: -

Identifier Source: org_study_id

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