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

NCT ID: NCT05810389

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-11-30

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.

Detailed Description

The 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.

All parents/caregivers of the children will receive a leaflet requesting the approval to enroll their children; for those families that decide not to be included into the trial, the children will receive the dental treatment needed but their data will not be evaluated.

The inclusion criteria were children between 4 and 11 years old attending the selected schools. Exclusion criteria: Children with systemic diseases or systemic disease treatments, motor disorders and children receiving preventive measures in other public, private, or social security dental services.

Clinical examinations

Each child will go under a clinical examination to determine dental status according to the ICDAS II criteria (Pitts, 2005), perform under standardized conditions, using light, dental mirror, WHO probe and magnification (2,5x). The dental exams will be performed by calibrated researchers.

On the basis of the clinical examination, beside the ICDAS11,12 score, the Caries Treatment Need Index13 (CTNI) will also be registered.

Intervention

As described above, the children will be divided into three different groups according to the mode of treatment:

• NaF varnish group (NaFV) n=60 children Professional application of 5% NaF varnish twice a year pH 7 (ClinPro White Varnish®) according to manufacturer's instructions.
• APF in tray Group (APFt) n=60 children 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) n=60 children Professional application of APF 1.23% twice a year pH 3.5 (Klepp®) with toothbrush 2 minutes brushing according to manufacturer's instructions.

Enrolment in each group will be given by balancing the CNTI categories in each group.

A protocol will be applied to all children, based on dental care programmes to be carried out in school and dental clinics, with the aim of controlling caries lesions, comprising: teaching and control of personal oral hygiene; dietary counseling, calculus removal, and caries treatment if needed.

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.

In all children, daily brushing will be performed with the same toothpaste and toothbrush, supervised by schoolteachers, with fluoride toothpaste (1400 ppm) at school.

Statistical analysis

All the data will be input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8). Chi -square test for NTCI changes between groups and after 24 months.

Kaplan - Meyer Statistical analyses will be performed using Stata/SE1 software, version Stata/SE 16.1 for Mac (Intel 64-bit)and SPSS 28 for survival of sound surfaces after 24 months and Hazard Ratio will be calculated.

Conditions

Caries,Dental

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FFA toothbrush

Group Type: EXPERIMENTAL

Fluoride

Intervention Type: COMBINATION_PRODUCT

Application methods of delivery of topical fluoride

Varnish

Group Type: ACTIVE_COMPARATOR

Fluoride

Intervention Type: COMBINATION_PRODUCT

Application methods of delivery of topical fluoride

FFA gel

Group Type: ACTIVE_COMPARATOR

Fluoride

Intervention Type: COMBINATION_PRODUCT

Application methods of delivery of topical fluoride

Interventions

Fluoride

Application methods of delivery of topical fluoride

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Toothbrush

Eligibility Criteria

Inclusion Criteria

• Schoolchildren

Exclusion Criteria

-

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

ALDO SQUASSI

Chairman Dept. Preventive and Community Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ALDO SQUASSI

Role: STUDY_DIRECTOR

University of Buenos Aires

Locations

Universidad de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

Other Identifiers

IISAP-OPYC001

Identifier Type: -

Identifier Source: org_study_id