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

NCT07161596 | Not Yet Recruiting

• 1 other identifier: oral healthstatus & hemophilia
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

aim of the study:

1. 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. 2.evaluate the effectiveness of oral health educational programs on the oral health status of the Egyptian hemophilic children

Conditions

Hemophilia

Keywords

oral hygiene index simplified; oral health related quality of life; oral health status; def; DMF; Hemophilic children

Outcome Measures

Primary Outcomes (1)

• oral health status in Egyptian hemophilic children

  Oral Health Status 1. 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. 2. 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. 3. 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.

  baseline

Secondary Outcomes (1)

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

  baseline

Study Arms (2)

hemophilic children: oral health educational program as intervention

EXPERIMENTAL

An oral health educational program delivered to hemophilic Egyptian children as the main intervention guided by the oral and dental care instructions recommended by the American Academy of Pediatric Dentistry (AAPD) and the World Federation of Hemophilia (WFH), and the oral care program by the Egyptian society of hemophilia

Behavioral: oral health educational program

hemophilic children: no oral health educational program (no intervention)

NO INTERVENTION

for ethical considerations; no intervention group will be given the oral health educational program after the follow up oral health status indices are measured

Interventions

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

hemophilic children: oral health educational program as intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Links

• AL-KHAYAL, Z. and BROWN, A. (2006) 'Validity and reliability of the Arabic translation of the child oral-health-related quality of life questionnaire (CPQ11-14) in Saudi Arabia', Wiley Online Library.
• Kabil, N., ElAlfy, M. S., and Metwalli, N. (2007) 'Evaluation of the oral health situation of a group of Egyptian haemophilic children and their re-evaluation following an oral hygiene and diet education programme', Haemophilia: The Official Journal of t
• Li, Y., et al. (2023) 'Oral health status and oral habits of children and adolescents with hemophilia: A report from the Children's Hemophilia Comprehensive Care Center of China', European Journal of Pediatrics, 183(2), pp. 897-902.

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

• Nevine G Waly, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hoda H Atteya, Master

CONTACT

01226407070; hoda.ibrahim@dentistry.cu.edu.eg

Ghadeer M Sayed, master

CONTACT

01023724105; ghadeer.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Student

Model Details: oral health educational program is used to measure the oral health status before and after

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: September 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)