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Trial registered on ANZCTR


Registration number
ACTRN12613000839707
Ethics application status
Approved
Date submitted
23/07/2013
Date registered
30/07/2013
Date last updated
30/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Fluoride Varnish on the Control of Dental Decay in the Temporary Teeth of Children Younger than 5 years of Age
Scientific title
Efficacy and Safety of a Twice-Yearly Fluoride Varnish Application versus Placebo Varnish Application used to Decrease Dental Caries Incidence in Preschool Children
Secondary ID [1] 282884 0
Nil
Universal Trial Number (UTN)
U1111-1131-5934
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 289702 0
Condition category
Condition code
Oral and Gastrointestinal 290024 290024 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fluoride varnish (5% Sodium Fluoride) was applied every six months, during two years, to the primary teeth of the children who were randomly allocated to the test group.
Intervention code [1] 287587 0
Prevention
Comparator / control treatment
Placebo varnish was applied every six months, during two years, to the primary teeth of the children who were randomly allocated to the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 290075 0
Caries incidence as measured by the proportion of children who developed new dentine caries lesions during the follow-up period. Dental caries assessment was performed by two trained Pediatric Dentists.
Timepoint [1] 290075 0
At two years after baseline caries assessment.
Primary outcome [2] 290076 0
Caries increment as measured by subtracting the number of decayed, filled and extracted tooth surfaces at baseline from the number of decayed, filled and extracted tooth surfaces at the end of the follow-up.
Timepoint [2] 290076 0
At two years after baseline caries assessment.
Secondary outcome [1] 303890 0
Safety and acceptability of the intervention as measured by the number of children/caretakers with complaints regarding the intervention (e.g., children: burning sensation in the mouth, nausea, altered taste, allergies or avoided smiling because of the yellowish color of the teeth after varnish application; caretakers: felt bothered by the yellowish color of the child's teeth after varnish application). In order to assess the safety and acceptability of the intervention parents were interviewed by telephone after the first varnish application.
Timepoint [1] 303890 0
At seven to ten days after the first varnish application.

Eligibility
Key inclusion criteria
Living in Rio de Janeiro city for at least one year and planning to reside in the city for the following two years, having a fixed address, and owning a telephone or having a close relative who owned a telephone.
Minimum age
1 Years
Maximum age
4 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having received a professional fluoride application in the previous six months, presenting more than ten dentine caries lesions, having a dental abscess or a systemic disease that could be aggravated by a dental problem (i.e., diabetes, rheumatic fever, heart disease or HIV infection).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was decided after contacting the holder of the allocation schedule who was not involved in examining the children or interviewing their caretakers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation used a computer generated sequence of random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size was planned to detect caries incidences of 33% and 15% in the control and test groups, respectively, with alpha=0.05 and power=0.80.Considering an attrition rate of 15%, sample size was increased from 170 to 200 subjects: 100 in each group. The absolute and relative risk reductions and the caries prevented fractions (with their 95% Confidence Intervals) were calculated using a statistical software. The Student T Test was used to compare the caries increment in the test and control groups after 2 years of follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5240 0
Brazil
State/province [1] 5240 0
Rio de Janeiro

Funding & Sponsors
Funding source category [1] 287670 0
University
Name [1] 287670 0
Rio de Janeiro State University/Piquet Carneiro Poyclinic/Faculty of Dentistry
Address [1] 287670 0
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro.
20551-030, Brazil.
Country [1] 287670 0
Brazil
Primary sponsor type
Individual
Name
Branca Heloisa de Oliveira
Address
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro.
20551-030, Brazil.
Country
Brazil
Secondary sponsor category [1] 286406 0
University
Name [1] 286406 0
Rio de Janeiro State University/Faculty of Dentistry
Address [1] 286406 0
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro.
20551-030, Brazil.
Country [1] 286406 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289634 0
Research Ethics Committee of Pedro Ernesto Hospital/Rio de Janeiro State University
Ethics committee address [1] 289634 0
77, 28 de Setembro Boulevard, Vila Isabel, Rio de Janeiro.
20551-030, Brazil.
Ethics committee country [1] 289634 0
Brazil
Date submitted for ethics approval [1] 289634 0
Approval date [1] 289634 0
22/03/2006
Ethics approval number [1] 289634 0
1422

Summary
Brief summary
The objective of this two-year randomized placebo-controlled trial was to assess whether the application of Fluoride varnish in preschool children at six-months intervals decreases the number of new caries lesions in their primary dentition. We also investigated whether this procedure is safe and well-accepted by the children themselves and their caretakers. At the beginning of the study, two hundred 1 to 4-year old children were allocated to the test (Fluoride varnish) or control (Placebo varnish) groups. The participants, their caretakers, examining dentists and the clinical staff did not know to each group each child was allocated. After the first varnish application, 183 children's caretakers were interviewed by telephone in order to know if they or their children had any complaints regarding the varnish application. Two years later, 181 children showed-up for dental examination (89 in the test group and 92 in the placebo group).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41654 0
Dr Branca Heloisa de Oliveira
Address 41654 0
Faculty of Dentistry/Rio de Janeiro State University (UERJ)
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro
22551-030, Brazil.
Country 41654 0
Brazil
Phone 41654 0
552128688272
Fax 41654 0
Email 41654 0
branca@uerj.br
Contact person for public queries
Name 41655 0
Dr Branca Heloisa de Oliveira
Address 41655 0
Faculty of Dentistry/Rio de Janeiro State University (UERJ)
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro
22551-030, Brazil.
Country 41655 0
Brazil
Phone 41655 0
552128688272
Fax 41655 0
Email 41655 0
branca@uerj.br
Contact person for scientific queries
Name 41656 0
Dr Branca Heloisa de Oliveira
Address 41656 0
Faculty of Dentistry/Rio de Janeiro State University (UERJ)
157, 28 de Setembro Blvd, Vila Isabel, Rio de Janeiro
22551-030, Brazil.
Country 41656 0
Brazil
Phone 41656 0
552128688272
Fax 41656 0
Email 41656 0
branca@uerj.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary