Oral Health Status in Children With β-Thalassemia Major

N/ANot Yet RecruitingNCT07614217

Cairo University45 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

B Thalassemia Major

Interventions

oral health educational program for Immediate Intervention GroupOTHER

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 instructionsOTHER

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Central Contacts

Mariam MohamedDia Shafie, Bachelor of Dental Surgery

CONTACT

+01226602585 mariam.diaaeldin@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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