MedTrace Logo

EVALUATION OF AN ALTERNATIVE TECHNIQUE FOR THE APPLICATION OF SODIUM FLUOROPHOSPHATE: A 2-YEARS DOUBLE-BLIND RCT

NCT05810389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-12

No results posted yet for this study

Summary

he study was designed as a double-blind three-parallel-group randomized controlled trial, in which the evaluators and a researcher, not involved in the evaluation process, was responsible for the randomization process, were masked to the group assignment.

The study will be carried out at 2 schools of the Metropolitan Area of Buenos Aires where school programs are developed by the Department of Preventive and Community Dentistry of the University of Buenos Aires, and that present homogeneous characteristics in terms of social risk. The children (n=244) attending those primary schools will be the population object of the trial.

Clinical examinations

Each child will go under a clinical examination to determine dental status according to the ICDAS II criteria (Pitts, 2005) and the Caries Treatment Need Index (CTNI).

Intervention

Children will be divided into three different groups according to the mode of treatment:

* NaF varnish group (NaFV) Professional application of 5% NaF varnish twice a year pH 7 (ClinPro White Varnish®) according to manufacturer's instructions.
* APF in tray Group (APFt) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with tray according to manufacturer's instructions
* APF in toothbrush group (APFtbru) Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with toothbrush 2 minutes brushing according to manufacturer's instructions.

Dental examination and Monitoring

Observations and clinical examinations will be conducted at schools. After 12 and 24 months, the clinical examination will be repeated to assess the dental status of schoolchildren following the same criteria described. The presence of new caries lesions will be taken as a dependent variable. So sound surfaces on baseline will be observed for 24 months.

Conditions

  • Caries,Dental

Interventions

COMBINATION_PRODUCT

Fluoride

Application methods of delivery of topical fluoride

Sponsors & Collaborators

  • University of Buenos Aires

    lead OTHER

Principal Investigators

  • ALDO SQUASSI · University of Buenos Aires

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810389 on ClinicalTrials.gov