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NCT Number: NCT07614217

Oral Health Status in Children With β-Thalassemia Major

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.

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Key information

Conditions

B Thalassemia Major

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral health educational program for Immediate Intervention Group

Other

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
  • Importance of mouth rinse and fluoridated tooth pastes

Materials Used

  • Ultra soft Toothbrushes
  • Alcohol-free mouth rinse
  • Use of fluoridated toothpaste
  • Interdental floss
  • Oral health promotion leaflet

routine oral hygiene instructions

Other

Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean

Primary outcomes

  1. Oral Hygiene

    Time frame: Baseline Measurement and After 1,3 and 6 months

    Oral Hygiene Index-Simplified (OHI-S)

    Minimum value: 0

    Maximum value: 6

    Interpretation of scores:

    Higher scores indicate worse oral hygiene (greater debris and calculus accumulation).

    Lower scores indicate better oral hygiene.

Secondary outcomes

  1. Oral Health Related Quality Of Life (OHRQoL)

    Time frame: Baseline and after 1,3 and 6 months

    Measured using Child Perception Questionnaire (children aged 8-10 years) Child Perceptions Questionnaire for children aged 8-10 years (CPQ8-10)

    Minimum value: 0

    Maximum value: 100

    Interpretation of scores:

    Higher scores indicate a worse oral health-related quality of life (greater negative impact on the child's well-being).

    Lower scores indicate a better oral health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam MohamedDia Shafie, Bachelor of Dental Surgery

CONTACT

[email protected]

+01226602585

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.