Effectiveness of supervised toothbrushing on prevention of childish dental caries

ISRCTN	ISRCTN18548869
DOI	https://doi.org/10.1186/ISRCTN18548869
Secondary identifying numbers	06/51300-0

Submission date: 03/11/2007
Registration date: 11/12/2007
Last edited: 30/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paulo Frazao
Scientific

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

Study information

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
Study setting(s)	Other
Study type	Prevention
Scientific title	Cost-effectiveness of supervised toothbrushing on prevention of dental caries in permanent molar first
Study objectives	To compare two techniques of direct supervised toothbrushing with fluoridated dentifrice on occurrence of caries lesions in permanent molar first.
Ethics approval(s)	Ethics approval received from the Research Ethical Committee from Catholic University of Santos on the 20th November 2005.
Health condition(s) or problem(s) studied	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
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 study start date	02/04/2007
Completion date	02/05/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	500 pre-school children
Key inclusion criteria	Eligible subjects with one or more sound erupted permanent molar first.
Key exclusion criteria	Infants with condition or disease that increase caries risk.
Date of first enrolment	02/04/2007
Date of final enrolment	02/05/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Carvalho de Mendonca 144 - 4th floor

Santos
11070906
Brazil

Sponsor information

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

c/o Dr Paulo Frazao
Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070-906
Brazil

Phone	+55 13 3205 5578
Email	pafrazao@usp.br
Website	http://www.unisantos.br
"ROR"	https://ror.org/00vcyhn10

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/03/2011		Yes	No