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NCT Number: NCT07161596

Oral Health Status and Oral Health Related Quality of Life in a Group pf Egyptian Hemophilic Children

aim of the study:

1. to assess, investigate, and compare the oral health status and oral health related quality of life of a group of hemophilic Egyptian children before and after an oral health educational program 2. evaluate the effectiveness of oral health educational programs on the oral health status of the Egyptian hemophilic children

benefits to patients: oral health awareness and change in the oral care levels with methods that match their health needs benefits to clinician: better understanding of the oral conditions associated with hemophilic patients, and their effects on oral health benefits to community: improvement of children's oral health, oral health awareness, promoting the importance of regular dental check ups for children with hemophilia

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In a non randomized clinical trial, Egyptian hemophilic children will be submitted to this trial to assess and measure their oral health status and oral health related quality of life prior to an oral health educational program. two groups will be formulated; the hemophilic group that will take the oral health educational program and the control group (other group) wont be taking the oral health educational program, then control will be given the oral health educational program after the follow up period for a better oral health in the hemophilic community. the oral health status will be recorded using two indices; DMF and def Caries indices and the oral hygiene index simplified (OHI-S) at baseline and at 8 months follow up period. bimonthly visits will be scheduled to check on the hemophilic children oral health and following up on given oral hygiene instructions. the oral health educational program is a tailored program guided by the American academy of pediatric dentistry, the oral considerations in the world federation of hemophilia , and oral care program of the Egyptian society of hemophilia in Egypt. diet counselling will be given. after the 8 months following the oral health educational program, oral health status and oral health related quality of life will be measured in both group and the results will be recorded. Aim of the study is a better oral health care and better understanding on how to apply oral hygiene measures correctly in hemophilic children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • both sexes having hemophilia A,B or C
  • no associated co morbid diseases
  • mild, moderate and severe forms of hemophilia
  • children whose parents agreed to participate in the study

Exclusion criteria

  • patients with psychiatric disorders
  • children whose parents refused to participate in the study
  • patients using drugs( as cyclosporine, phenytoin) inducing periodontal problems

Treatment and study plan

oral health educational program

Behavioral

oral health educational program to the hemophilic children guided by the oral and dental care instructions provided by the AAPD and World federation of hemophilia oral care instructions

Primary outcomes

  1. oral health status in Egyptian hemophilic children

    Time frame: baseline

    Oral Health Status

    • Dental Caries in Permanent Teeth (Decayed, Missing, and Filled Teeth Index) The Decayed, Missing, and Filled Teeth index records the number of decayed, missing due to caries, and filled permanent teeth. A mean score is calculated for the study group.

    Mean DMFT score. Minimum value: 0 - Maximum value: 28. Higher scores indicate worse oral health status.

    • Dental Caries in Primary Teeth (Decayed, Extracted, and Filled Teeth Index) The Decayed, Extracted, and Filled Teeth index records decayed, extracted due to caries, and filled primary teeth. A mean def score is reported for the study group.

    Minimum value: 0 - Maximum value: 20. Higher scores indicate worse oral health status.

    • Oral Hygiene Status (Oral Hygiene Index-Simplified) The Oral Hygiene Index-Simplified combines debris and calculus scores to assess oral hygiene status Mean score.

    least value: 0 - Max:6 Lower score indicate better oral hygiene, and higher scores indicate worse oral hygiene.

Secondary outcomes

  1. oral health related quality of life of a group of Egyptian hemophilic and non hemophilic children

    Time frame: baseline

    Oral Health-Related Quality of Life 4. CPQ11-14 Total Score The validated Arabic Child Perceptions Questionnaire (CPQ11-14) includes 36 items across four domains: oral symptoms, functional limitations, emotional well-being, and social well-being. The sum of all items provides a total score. Higher scores indicate greater negative impact.

    Unit of Measure: Mean CPQ11-14 total score (range 0-144) 5. CPQ11-14 Domain Scores Description: Sub scores are reported separately for oral symptoms, functional limitations, emotional well-being, and social well-being.

    Unit of Measure: Mean domain score (Oral symptoms: 0-24; Functional limitations: 0-36; Emotional well-being: 0-36; Social well-being: 0-48) 6. Global Rating of Oral Health Description: Children provide a self-assessment of oral health: excellent, very good, good, acceptable, or bad.

    Unit of Measure: Ordinal score (0 = excellent, 1 = very good, 2 = good, 3 = acceptable, 4 = bad) 7. Overall Well-Being Impact of Oral Health ordinal score

Study contacts

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

Ghadeer M Sayed, master

CONTACT

[email protected]

01023724105 ext. +20

Hoda H Atteya, Master

CONTACT

[email protected]

01226407070 ext. +20

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Oral Health Status and Oral Health Related Quality of Life of a Group of Hemophilic Egyptian Children Before and After an Oral Health Educational Program: A Before and After Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Jan 23, 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.

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