Oral Health and Dental Caries Prevention Intervention for Children in Romania

NCT06441500 | Recruiting

• 1 other identifier: 18688/16.10.2023
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 5

Brief 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. 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. 2.A toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery.
3. 3.Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries.

Conditions

Dental Caries; Early Childhood Caries; Quality of Life

Keywords

dental caries; quality of life; diet; socio-economic status; county development index

Outcome Measures

Primary Outcomes (5)

• Epidemiologic baseline data on caries prevalence

  Prevalence will be determined for the specific age group after primary examination using ICDAS criteria after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". To evaluate the outcomes, a statistical analysis will be performed. All the data will be input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8).The total number of existing caries will serve for the calculation of the dmft index (decayed-missing-filled teeth index) and the SiC index (Significant caries index).

  3 months

• Epidemiologic baseline data on caries severity

  Clinical examinations will be performed using ICDAS criteria by calibrated medical staff from each partner university after calibration. Children will be examined in a seated position, using a dental mirror and a probe, without air-drying. Thus, ICDAS codes 1 and 2 will be counted together as "A". Statistical analysis will be performed after inputing the data into a sheet (Microsoft Excel 2021 for Mac, version 16.4.8). Severity will be determined for the specific age group after primary examination using ICDAS criteria. ICDAS codes of 0 represent sound teeth, codes of 1 and 2 represent initial reversible caries lesions, only affecting the enamel, codes of 3 represent initial microcavitation of the enamel, codes of 4 represent moderate carious lesions and codes of 5 and 6 represent extended lesions.

  3 months

• Epidemiologic baseline self assessment data

  Self-assessment of oral health behaviours of children will be done using the previously designed questionnaire from the National Oral Health Survey. The working tool consists of 15 items that make up the two types of behaviour (prevention and diet), and family characteristics (parent's level of education, working status). Behaviours will be correlated with clinical indices that will help us to delimit the existence or lack of certain significant differences among children. For a better understanding of the risk factors the evaluation relates to specific elements of the child (gender, age, parental education, residence), and elements related to the objective living conditions (county development index, residence, etc.). Statistical analysis using Poisson regression will correlate data obtained from self assessment with clinical outcomes expressed by the dmft index.

  3 months

• Monitor caries activity

  Follow-up data regarding changes in caries status: new lesions appearing or existing caries status changes at interim and last examination. Caries incidence rate will be calculated on each tooth as the unit of analysis and evaluated using a multi-step approach: A - The net caries increment for initial, moderate, and extensive caries severity using ICDAS (Δ-initial, Δ- moderate, and Δ- extensive) will be calculated at each follow-up examinations; B - Events will be defined as a tooth getting a lesion or as the sum of the Δ-caries changes of status recorded at the baseline examination, at interim, and at the last examination. The number of events will be appraised by subtracting the number of caries-free teeth at last examination from those at baseline. The non-parametric Mann-Whitney U test will be applied to assess the differences across mean number of events between groups.

  18 months

• Efficacy of the treatment

  The efficacy of the treatment will be assessed for those who fully followed the protocol (per-protocol subjects) by calculating the reduction in risk ratio (RR) and the related number needed to treat (NNT) value. An event is defined as the change of status at tooth level, i.e. the development of a new lesion or the progression of an existing lesion to a more severe stage. Cox Proportional Hazards models will be run to assess the factors associated with caries change of status. Estimates will be reported in the hazard ratio (HR) and their respective 95% confidence interval (95%CI). For all statistical analyses, the statistical significance will be set at α=0.05

  18 months

Secondary Outcomes (3)

• Daily tooth brushing pattern

  12 months

• Qualitative evaluation of the preventive activities in nurseries

  12 months

• Qualitative evaluation of oral health promotion activities

  12 months

Study Arms (1)

Kindergarten children

EXPERIMENTAL

Children aged 3-5 years, enrolled in kindergartens. The pathfinder sampling technique has been used to obtain a representative sample. As suggested by the WHO, this survey design is suitable for collection of data for planning purposes and monitoring of oral health programmes in all countries regardless of the level of disease, availability of resources or complexity of care. Clinical examinations will be performed using ICDAS criteria by calibrated medical staff from each partner university. Caries incidence rate will be calculated on each tooth as the unit of analysis and evaluated using a multi-step approach: net increment for caries severity using ICDAS calculated at each follow-up examinations; Events defined as a new lesion or as the sum of the Δ-caries changes of status recorded at the baseline, at interim, and at the last examination. The number of events will be appraised by subtracting the number of caries-free teeth at last examination from those at baseline.

Other: Daily tooth brushing programme

Interventions

Daily tooth brushing programme OTHER

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.

Kindergarten children

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 3-5 years attending public nurseries in Romania

You may not qualify if:

• enamel fluorosis
• enamel developmental defects
• incapacity to perform tooth brushing by themselves

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead
• Carol Davila University of Medicine and Pharmacy: collaborator
• Grigore T. Popa University of Medicine and Pharmacy: collaborator
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator
• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures: collaborator
• University of Medicine and Pharmacy Craiova: collaborator

Study Sites (5)

University of Medicine and Pharmacy Cluj-Napoca

Cluj-Napoca, Cluj, 400083, Romania

RECRUITING

University of Medicine and Pharmacy Craiova

Craiova, Dolj, 200349, Romania

RECRUITING

County School Inspectorate Iasi

Iași, Iaşi, Romania

RECRUITING

University of Medicine and Pharmacy Targu Mures

Târgu Mureş, Mureș County, 540142, Romania

RECRUITING

University of Medicine and Pharmacy Bucharest

Bucharest, 050037, Romania

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ruxandra Sava-Rosianu

  Victor Babes University if Medicine and Pharmacy Timisoara Romania

  STUDY DIRECTOR

Central Study Contacts

Ruxandra Sava-Rosianu, DMD, PhD

CONTACT

740315848; sava-rosianu.ruxandra@umft.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of grant department

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: June 4, 2024
• Study Start: January 7, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 21, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (5)