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aim of the study:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| oral health status in Egyptian hemophilic children | Oral Health Status
least value: 0 - Max:6 Lower score indicate better oral hygiene, and higher scores indicate worse oral hygiene. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| oral health related quality of life of a group of Egyptian hemophilic and non hemophilic children | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hoda H Atteya, Master | Contact | 01226407070 | +20 | hoda.ibrahim@dentistry.cu.edu.eg |
| Ghadeer M Sayed, master | Contact | 01023724105 | +20 | ghadeer.mohamed@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nevine G Waly, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
|
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| Label | URL |
|---|---|
| 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. | View source |
| 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 | View source |
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Individual participant data (IPD) will not be shared. No supporting documents will be made publicly available.
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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oral health educational program is used to measure the oral health status before and after
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| baseline |
| 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. | View source |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |