Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control

NCT ID: NCT01501357

Last Updated: 2018-03-21

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

multilevel filaments toothbrush

Children will brush with anteroposterior toothbrushing and a modified toothbrush (multilevel filaments)

Group Type EXPERIMENTAL

modified toothbrush with multilevel filaments

Intervention Type BEHAVIORAL

After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.

cross toothbrushing

Children will brush with cross toothbrushing.

Group Type ACTIVE_COMPARATOR

cross toothbrushing

Intervention Type BEHAVIORAL

Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

modified toothbrush with multilevel filaments

After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.

Intervention Type BEHAVIORAL

cross toothbrushing

Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

stages, oral b buccal-lingual technique

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* erupting primary permanent molar

Exclusion Criteria

* caries ( ICDAS 4,5 and 6),
* enamel defects,
* sealant,
* restoration
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mariana Minatel Braga

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mariana M Braga, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade de São Paulo

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy of an Automatic Toothbrush
NCT05594134 COMPLETED NA