Condition category
Oral Health
Date applied
03/11/2007
Date assigned
11/12/2007
Last edited
30/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paulo Frazao

ORCID ID

Contact details

Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070906
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/51300-0

Study information

Scientific title

Cost-effectiveness of supervised toothbrushing on prevention of dental caries in permanent molar first

Acronym

Study hypothesis

To compare two techniques of direct supervised toothbrushing with fluoridated dentifrice on occurrence of caries lesions in permanent molar first.

Ethics approval

Ethics approval received from the Research Ethical Committee from Catholic University of Santos on the 20th November 2005.

Study design

An interventional community-randomised controlled single-centre trial will be conducted in six preschools with 5 - 6 year-old children.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Caries lesion on surface of permanent molar first

Intervention

Intervention group:
A modified technique of direct supervised toothbrushing with fluoridated dentifrice will be carried out in eligible children every 45 days in three randomly selected preschools (test-units). The modified technique includes professional toothbrushing on occlusal surfaces of permanent molar first carried out by trained auxiliary personnel.

Control group:
A conventional technique of direct supervised toothbrushing with same fluoridated dentifrice will be carried out in eligible children every 90 days in three preschools (control-units).

Total duration of intervention and follow-up is the same: twenty-four months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Enamel caries measured by visual exam with aid of a ball point instrument recommended by World Health Organization. The outcomes will be measured at first, 6th, 12th and 18th month.

Secondary outcome measures

Dentine caries measured by visual exam with aid of a ball-point instrument recommended by World Health Organization. The outcomes will be measured at first, 6th, 12th and 18th month.

Overall trial start date

02/04/2007

Overall trial end date

02/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible subjects with one or more sound erupted permanent molar first.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500 pre-school children

Participant exclusion criteria

Infants with condition or disease that increase caries risk.

Recruitment start date

02/04/2007

Recruitment end date

02/05/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070906
Brazil

Sponsor information

Organisation

Catholic University of Santos (Universidade Catolica de Santos) (Brazil)

Sponsor details

c/o Dr Paulo Frazao
Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070-906
Brazil
+55 13 3205 5578
pafrazao@usp.br

Sponsor type

University/education

Website

http://www.unisantos.br

Funders

Funder type

Government

Funder name

State of Sao Paulo Research Foundation (Fundacao de Amparo a Pesquisa do Estado de Sao Paulo [FAPESP]) (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21426572

Publication citations

  1. Results

    Frazão P, Effectiveness of the bucco-lingual technique within a school-based supervised toothbrushing program on preventing caries: a randomized controlled trial., BMC Oral Health, 2011, 11, 11, doi: 10.1186/1472-6831-11-11.

Additional files

Editorial Notes