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

NCT05810389 | Completed Phase 4

• 1 other identifier: IISAP-OPYC001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Caries incidence reduction

  24 months

Study Arms (3)

FFA toothbrush

EXPERIMENTAL

Combination Product: Fluoride

Varnish

ACTIVE COMPARATOR

Combination Product: Fluoride

FFA gel

ACTIVE COMPARATOR

Combination Product: Fluoride

Interventions

Fluoride COMBINATION_PRODUCT

Application methods of delivery of topical fluoride

Also known as: Toothbrush

FFA gel; FFA toothbrush; Varnish

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Schoolchildren

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (1)

Universidad de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1122, Argentina

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• ALDO SQUASSI

  University of Buenos Aires

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Dept. Preventive and Community Dentistry

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

AR (1)