B Thalassemia Major
Conditions
Keywords
oral health related quality of life, oral health status, Beta Thalassemia Major children
Brief summary
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
OTHERoral 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 * 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
OTHERroutine oral hygiene instructions
Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Participants will be allocated into two groups: an immediate intervention group and a waitlist control group. Both groups will undergo baseline assessment. The intervention group will receive the structured oral health educational program, while the waitlist group will receive routine care. After 3 months, both groups will be reassessed. Subsequently, the educational program will be provided to the waitlist group to ensure ethical equity.
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Hygiene | 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
| Measure | Time frame | Description |
|---|---|---|
| Oral Health Related Quality Of Life (OHRQoL) | 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. |
Contacts
CONTACTMariam MohamedDia Shafie, Bachelor of Dental Surgery
Outcome results
None listed