Oral Health Status in Children With β-Thalassemia Major

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: B Thalassemia Major
• Intervention / Treatment: Other: oral health educational program for Immediate Intervention Group; Other: routine oral hygiene instructions

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam MohamedDia Shafie, Bachelor of Dental Surgery; Phone Number: +01226602585; Email: mariam.diaaeldin@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: an Immediate Intervention Group; oral health educational program will be given to this group of patients	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; 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
Placebo Comparator: Waitlist Control Group; routine oral hygiene instructions will be given to this group of children	Other: routine oral hygiene instructions; Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Hygiene	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.	Baseline Measurement and After 1,3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health Related Quality Of Life (OHRQoL)	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.	Baseline and after 1,3 and 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General 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 version of the child perceptions questionnaire for 8-10-year-old children', Quality of Life Research, 29(11), pp. 3119-3125. Available at: https://doi.org/10.1007/s11136-020-02545-y. Amirabadi, F., Saravani, S., Miri-Aliabad, G., Khorashadi-Zadeh, M. (2019). 'The Association between Dental Health Status and Oral Health-Related Quality of Life of Children Diagnosed with β-Thalassemia Major in Zahedan City, Iran', Journal of Pediatric Perspectives, 7(2), pp. 8985-8991. doi: 10.22038/ijp.2018.34517.3034 Barriault, S., Deneault, A.-A., Kempe, S., Madigan, S., Lovegrove, A., Dimitropoulos, G., Pillai Riddell, R. and Racine, N. (2019) 'A randomized waitlist control trial of the Make the Connection® online program for caregivers of infants and young children: Study protocol', BMC Pediatrics, 19, p. 176. https://doi.org/10.1186/s12887-019-1567-2 Desveaux, L., Agarwal, P., Shaw, J., Hensel, J.M., Mukerji, G., Onabajo, N., Marani, H., Jamieson, T., Bhattacharyya, O., Martin, D., Mamdani, M., Jeffs, L., Wodchis, W.P., Ivers, N.M. and Bhatia, R.S. (2018) 'A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol', BMC Medical Informatics and Decision Making, 18, Article 49. https://doi.org/10.1186/s12911-018-0613-5 El-Kamah, G., Adam, S., Magdy, P., Michel, M. and Afifi, H. (2014) 'Quality of life outcomes among Egyptian children with beta-thalassemia', Blood, 124(21), p. 4864. Fadel, H.T., Zolaly, M.A., Alharbi, M.O., Qarah, L.A., Alrehili, M.S., Alamri, A.D. and Tarawah, A.M. (2

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: oral health related quality of life; oral health status; Beta Thalassemia Major children
• Other Study ID Numbers: OHRQOL in β-TM children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No