Home » Trials » SLCTR/2019/009


Cost effectiveness of two preventive methods in the incidence of caries. Controlled clinical trial.

-

SLCTR Registration Number

SLCTR/2019/009


Date of Registration

10 Mar 2019

The date of last modification

Mar 10, 2019



Application Summary


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


Trial Details


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.

  • The application for the varnish will be carried out every three months and the application of the sealants will only be carried out if necessary.

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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