Home » Trials » SLCTR/2019/009
Cost effectiveness of two preventive methods in the incidence of caries. Controlled clinical trial.
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SLCTR Registration Number
SLCTR/2019/009
Date of Registration
The date of last modification
Sep 16, 2020
Scientific Title of Trial
Cost effectiveness of two preventive methods in the incidence of caries. Controlled clinical trial.
Public Title of Trial
Comparison of the cost effectiveness of fluoride varnish versus pit sealants and fissures in reducing the incidence of caries in children- A Randomized controlled clinical trial
Disease or Health Condition(s) Studied
Oral health, Caries.
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1220-3045
Any other number(s) assigned to the trial and issuing authority
ERC- Cinv/ICSa/#0024/2018
What is the research question being addressed?
What is the cost / effectiveness of pit and fissure sealants compared to fluoride varnish when used in the, First Permanent Molar for 6-8 year olds in public elementary schools?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study setting – Elementary schools in Hidalgo State, Mexico. Randomization method- Using the random number function excel.
Intervention -
Group 1 - Sealants of pits and fissures. Application of sealants of pits and fissures will be made through the total-etch technique
Group 2 - -fluoride varnish. Application of varnish of fluoride by through prior prophylaxis and use of micro brush.
Inclusion criteria
• Children between 6 and 8 years of age. • Have at least one permanent first molars healthy and totally erupted. • That belong to the selected school. That their parents accept and sign the informed consent. • The children allow oral exploration and application of sealants.
Exclusion criteria
• Children with fixed orthodontic appliances • Children with different capabilities. • Any systemic pathology • Any alteration of the oral cavity
Primary outcome(s)
|
1.
The incidence of caries as measured by using the visual method and the measurement system will be ICDAS. ICDAS: International Caries Detection and Assesment System |
[ 6 months, 1 year ] |
Secondary outcome(s)
|
1.
Cost of each intervention The cost will be measured as follows: 1. Total cost of each intervention 2. Time needed for each application 3. Number of times that requires reapplication. |
[ 6 months, 1 year ] |
Target number/sample size
228 (114 in each group)
Countries of recruitment
Mexico
Anticipated start date
2019-03-25
Anticipated end date
2019-07-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Universidad Autónoma del Estado de Hidalgo
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-10-04
Approval number
Cinv/148/2018
Details of Ethics Review Committee
| Name: | Committee of Ethics and Research, Department of Research, , School of Health Sciences, Universidad Autónoma del Estado de Hidalgo,Mexico |
| Institutional Address: | Circuito Ex Hacienda La Concepcion S/N Carretera Tlaxiaca, Hidalgo. Mexico. C.P 421 |
| Telephone: | 52(771)71 720-00 Ext. 5104 |
| Email: | psicologia@uaeh.edu.mx |
Contact person for Scientific Queries/Principal Investigator
Carlo Eduardo Medina Solís
Full-time research professor
Circuito Ex Hacienda La Concepción S/N Carretera Pachuca Actopan, San Agustín Tlaxiaca, Hidalgo
(771) 71 720 00 Ext. 4301
7711899294
None
cemedinas@yahoo.com
None
Contact Person for Public Queries
Miguel Angel Fernández Barrera
professor
Circuito Ex Hacienda La Concepción S/N Carretera Pachuca Actopan, San Agustín Tlaxiaca, Hidalgo
(771) 71 720 00 Ext. 4301
7711276265
None
mafba.mafb@gmail.com
Primary study sponsor/organization
Universidad Autónoma del Estado de Hidalgo
Circuito Ex Hacienda La Concepción S/N Carretera Pachuca Actopan, San Agustín Tlaxiaca, Hidalgo
(771) 71 720 00 Ext. 4301
cemedinas@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Data Sharing Plan Individual participant data will be available - Data available on request from the authors Data in particular will be shared - Data available on request from the authors Other documents will be available - Not applicable The dates on data will be available - Not applicable Types of analyses - Analyses available on request from the authors
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
