Oral Health Status in Children With β-Thalassemia Major

ConditionB Thalassemia Major

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-10

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children having medical records confirmed of β-thalassemia diagnosis.

Age range between 8-10 years old.

Have acceptable cooperation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

oral health educational program for Immediate Intervention Group
Other intervention
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 intervention
Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean

Treatment groups

46 Participants

are divided into 2 treatment groups

Group A: an Immediate Intervention GroupExperimental treatment 1 intervention

Group B: Waitlist Control GroupPlacebo comparator 1 intervention

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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