Menu
Not yet recruiting NCT07614217

Oral Health Status in Children With β-Thalassemia Major

No phase Interventional B Thalassemia Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oral health educational program for Immediate Intervention Group, routine oral hygiene instructions.
Who it may be relevant to
Registry conditions: B Thalassemia Major. Basic parameters: 8 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of a Structured Oral Health Educational Program on Oral Hygiene and Oral Health Related Quality of Life in Children With β-Thalassemia Major: Before and After Interventional Study.

Overview

To evaluate the effectiveness of a structured oral health educational program on oral hygiene status and oral health-related quality of life (OHRQoL) among children diagnosed with β-thalassemia.

Detailed description

Benefits to the patient

* The clinical examination and OHRQoL assessments provide a well-established foundation to plan the oral-dental treatment for each individual. * Improved awareness among β-thalassemia patients and caregivers regarding oral hygiene practices and the importance of regular dental visits may contribute to better oral health outcomes and enhanced overall quality of life.

Benefits to the community

* Provide valuable epidemiological data on the oral health status and oral health-related quality of life in children with β-thalassemia. * Assist dental professionals, healthcare providers, and policymakers in planning targeted preventive strategies and integrating oral health care into the comprehensive management of thalassemia.

Interventions

  • Other oral health educational program for Immediate Intervention Group
    Oral Health Educational Program Educational Content (Oral health educational session) including: * Interactive lectures with visual aids and video demonstration * Correct Tooth brushing technique * Frequency \& time of brushing * How to use mouth rinse and toothpaste * How to properly use the dental floss Teaching Methods * Demonstration on dental models * Hands-on supervised brushing * Use of disclosing agents Motivational Interviewing * Caregiver's guide booklet * Dietary counseling * Im
  • Other routine oral hygiene instructions
    Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean

Primary outcome measures

  • Oral Hygiene [Time frame: Baseline Measurement and After 1,3 and 6 months]
Secondary outcome measures (1)
  • Oral Health Related Quality Of Life (OHRQoL) [Time frame: Baseline and after 1,3 and 6 months]

Eligibility criteria

Inclusion criteria

  • Children having medical records confirmed of β-thalassemia diagnosis.
  • Age range between 8-10 years old.
  • Have acceptable cooperation

Exclusion criteria

  • Children with Cognitive impairment.
  • Participants in another oral health education program or clinical study within the past 6 months will be excluded.
  • Unstable clinical condition as judged by the treating physician

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Abbas, F., Tabesh, A., Yavari, A., Makaremi, R., Bizhani, O. and Mahmood, M. (2023) 'Evaluation and relation of oral health-related quality of life and oral health status in Thalassemia Major patients, a cross-sectional study', BMC Oral Health, 23(493), pp. 1-9. Available at: doi.org. Al-Blaihed, D., El-Housseiny, A.A., Farsi, N.J. and Farsi, N.M. (2020) 'Validity and reliability of the Arabic ver

Identifiers

NCT: NCT07614217 · OHRQOL in β-TM children

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗