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

April 11, 2023 updated by: ALDO SQUASSI, University of Buenos Aires

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Caba
      • Buenos Aires, Caba, Argentina, 1122
        • Universidad de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Schoolchildren

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FFA toothbrush
Combination product: Fluoride
Application methods of delivery of topical fluoride
Other Names:
  • Toothbrush
Active Comparator: Varnish
Combination product: Fluoride
Application methods of delivery of topical fluoride
Other Names:
  • Toothbrush
Active Comparator: FFA gel
Combination product: Fluoride
Application methods of delivery of topical fluoride
Other Names:
  • Toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caries incidence reduction
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Buenos Aires

Investigators

  • Study Director: ALDO SQUASSI, University of Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISAP-OPYC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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