Actively Recruiting

Phase Not Applicable
Age: 3Years - 5Years
All Genders
Healthy Volunteers
NCT06441500

Oral Health and Dental Caries Prevention Intervention for Children in Romania

Led by University of Medicine and Pharmacy "Victor Babes" Timisoara · Updated on 2024-06-04

500

Participants Needed

5

Research Sites

102 weeks

Total Duration

On this page

Sponsors

U

University of Medicine and Pharmacy "Victor Babes" Timisoara

Lead Sponsor

C

Carol Davila University of Medicine and Pharmacy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Oral Health and Dental Caries Prevention Intervention for Children in Romania

Who Can Participate

Age: 3Years - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 5 years attending public nurseries in Romania
Not Eligible

You will not qualify if you...

  • Enamel fluorosis
  • Enamel developmental defects
  • Inability to brush teeth by themselves

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Medicine and Pharmacy Cluj-Napoca

Cluj-Napoca, Cluj, Romania, 400083

Actively Recruiting

2

University of Medicine and Pharmacy Craiova

Craiova, Dolj, Romania, 200349

Actively Recruiting

3

County School Inspectorate Iasi

Iași, Iaşi, Romania

Actively Recruiting

4

University of Medicine and Pharmacy Targu Mures

Târgu Mureş, Mureș County, Romania, 540142

Actively Recruiting

5

University of Medicine and Pharmacy Bucharest

Bucharest, Romania, 050037

Actively Recruiting

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Research Team

R

Ruxandra Sava-Rosianu, DMD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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