Oral Health and Dental Caries Prevention Intervention for Children in Romania

NCT06441500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-06-04

No results posted yet for this study

Summary

During 2019-2020, the National Oral Health Survey evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health. Data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature of oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme.

The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste, which the study set out to evaluate. This programme could represent an example of good practice for the countries in our region, starting from downstream oral health interventions, such as clinical prevention and oral health promotion, and developing towards upstream interventions.

The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care.

The programme is structured on three levels:

1. Specific training for dental hygienists to deliver oral health promotion to children and nursery educators, focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries.
2. A toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery.
3. Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries.

The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children. Due to the fact that it is a pilot programme aiming to be further implemented at national level, an evolving model of evaluation is appropriate. This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings.

Conditions

  • Dental Caries
  • Early Childhood Caries
  • Quality of Life

Interventions

OTHER

Daily tooth brushing programme

Implementing the toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 - 5-year old child attending nursery. Free distribution of toothpaste/toothbrush packs to every child every 3 months. Collection of routine monitoring data linked with national data sets from the previous survey regarding caries prevalence and risk factors.2.Monitor caries activity - net caries increment for initial, moderate, and extensive caries severity.

Sponsors & Collaborators

  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER
  • Grigore T. Popa University of Medicine and Pharmacy

    collaborator OTHER
  • Iuliu Hatieganu University of Medicine and Pharmacy

    collaborator OTHER
  • George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

    collaborator OTHER
  • University of Medicine and Pharmacy Craiova

    collaborator OTHER
  • University of Medicine and Pharmacy "Victor Babes" Timisoara

    lead OTHER

Principal Investigators

  • Ruxandra Sava-Rosianu · Victor Babes University if Medicine and Pharmacy Timisoara Romania

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-07
Primary Completion
2024-11-30
Completion
2025-12-21

Countries

  • Romania

Study Locations

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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 NCT06441500 on ClinicalTrials.gov