HemophiliaNCT07161596
Oral Health Status and Oral Health Related Quality of Life in a Group pf Egyptian Hemophilic Children
A study testing oral health educational program in people with Hemophilia, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Hemophilia
- What is being tested?
- oral health educational program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- patients with psychiatric disorders
- children whose parents refused to participate in the study
- patients using drugs( as cyclosporine, phenytoin) inducing periodontal problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo
Passant M Nagi, PHD, +201280557107, passant.nagi@dentistry.cu.edu.eg
Hoda Ha Atteya, BDS
About this study
Official 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
aim of the study:
- 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
- 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
Read the detailed description
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.
- Conditions
- Hemophilia
- Being tested
- oral health educational program
- Keywords
- oral hygiene index simplified, oral health related quality of life, oral health status, def, DMF, Hemophilic children
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral health educational programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health status in Egyptian hemophilic children
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.
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- oral health educational program is used to measure the oral health status before and after
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Hatem Abdelmoniem Ibrahim Atteya, Cairo University
- Investigators
- Nevine G Waly, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161596
- Sponsor's protocol ID
- oral healthstatus & hemophilia
- Status last verified
- Jan 2026
- First submitted
- 18 Jun 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. No supporting documents will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07161596
- Acronym / sponsor ID
- oral healthstatus & hemophilia
- Conditions
- Hemophilia
- Keywords
- oral hygiene index simplified, oral health related quality of life, oral health status, def, DMF, Hemophilic children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
aim of the study:
- 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
- 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
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- oral health educational program is used to measure the oral health status before and after
| Arm | Type | Receives |
|---|---|---|
| hemophilic children: oral health educational program as intervention | Experimental | Behavioral: oral health educational programAn 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients with psychiatric disorders
- children whose parents refused to participate in the study
- patients using drugs( as cyclosporine, phenytoin) inducing periodontal problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral health educational programoral 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 | Behavioural | hemophilic children: oral health educational program as intervention |
Primary outcome
oral health status in Egyptian hemophilic children
Time frame: baseline
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.
1 secondary outcome
oral health related quality of life of a group of Egyptian hemophilic and non hemophilic children
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- 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.Link provided by the sponsor.
- 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 tLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. No supporting documents will be made publicly available.
Related trials for Hemophilia
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nevine G Waly, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral health educational program in people with Hemophilia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hoda H Atteya, Master (01226407070 ext. +20, hoda.ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health status in Egyptian hemophilic children (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.