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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21426572
Publication citations
-
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.