NCT01501357

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

December 20, 2011

Last Update Submit

March 20, 2018

Conditions

Caries

Keywords

cariesprimary molarsplaquetoothbrushing

Outcome Measures

Primary Outcomes (1)

  • dental caries

    24 months

Secondary Outcomes (1)

  • dental plaque

    24 months

Study Arms (2)

multilevel filaments toothbrush

EXPERIMENTAL

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

Behavioral: modified toothbrush with multilevel filaments

cross toothbrushing

ACTIVE COMPARATOR

Children will brush with cross toothbrushing.

Behavioral: cross toothbrushing

Interventions

modified toothbrush with multilevel filamentsBEHAVIORAL

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

Also known as: stages, oral b
multilevel filaments toothbrush
cross toothbrushingBEHAVIORAL

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

Also known as: buccal-lingual technique
cross toothbrushing

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • erupting primary permanent molar

You may not qualify if:

  • caries ( ICDAS 4,5 and 6),
  • enamel defects,
  • sealant,
  • restoration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mariana M Braga, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 29, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

BR(1)