B Thalassemia MajorNCT07614217
Oral Health Status in Children With β-Thalassemia Major
A study testing oral health educational program for Immediate Intervention Group and routine oral hygiene instructions in people with B Thalassemia Major, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- B Thalassemia Major
- What is being tested?
- oral health educational program for Immediate Intervention Group and routine oral hygiene instructions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Dec 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children having medical records confirmed of β-thalassemia diagnosis.
- Age range between 8-10 years old.
- Have acceptable cooperation
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mariam MohamedDia Shafie, Bachelor of Dental Surgery contact
About this study
Official title: Effectiveness of a Structured Oral Health Educational Program on Oral Hygiene and Oral Health Related Quality of Life in Children With β-Thalassemia Major: Randomized Clinical 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.
Read the detailed description
Benefits to the patient
- The clinical examination and OHRQoL assessments provide a well-established foundation to plan the oral-dental treatment for each individual.
- Improved awareness among β-thalassemia patients and caregivers regarding oral hygiene practices and the importance of regular dental visits may contribute to better oral health outcomes and enhanced overall quality of life.
Benefits to the community
- Provide valuable epidemiological data on the oral health status and oral health-related quality of life in children with β-thalassemia.
- Assist dental professionals, healthcare providers, and policymakers in planning targeted preventive strategies and integrating oral health care into the comprehensive management of thalassemia.
- Conditions
- B Thalassemia Major
- Being tested
- oral health educational program for Immediate Intervention Group, routine oral hygiene instructions
- Keywords
- oral health related quality of life, oral health status, Beta Thalassemia Major children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral health educational program for Immediate Intervention GroupOther
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 instructionsOther
Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean
| Study group | Role | What they receive |
|---|---|---|
| an Immediate Intervention Group | Experimental | oral health educational program will be given to this group of patients Receives: Other: oral health educational program for Immediate Intervention Group |
| Waitlist Control Group | Placebo comparator | routine oral hygiene instructions will be given to this group of children Receives: Other: routine oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Measurement and After 1,3 and 6 months
Secondary outcomes (1)
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.
Measured: Baseline and after 1,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B Thalassemia MajorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated into two groups: an immediate intervention group and a waitlist control group. Both groups will undergo baseline assessment. The intervention group will receive the structured oral health educational program, while the waitlist group will receive routine care. After 3 months, both groups will be reassessed. Subsequently, the educational program will be provided to the waitlist group to ensure ethical equity.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Mohamed Diaa eldin Shafie, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614217
- Sponsor's protocol ID
- OHRQOL in β-TM children
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbas, F., Tabesh, A., Yavari, A., Makaremi, R., Bizhani, O. and Mahmood, M. (2023) 'Evaluation and relation of oral health-related quality of life and oral health status in Thalassemia Major patients, a cross-sectional study', BMC Oral Health, 23(493), pp. 1-9. Available at: doi.org. Al-Blaihed, D., El-Housseiny, A.A., Farsi, N.J. and Farsi, N.M. (2020) 'Validity and reliability of the Arabic version of the child perceptions questionnaire for 8-10-year-old children', Quality of Life Research, 29(11), pp. 3119-3125. Available at: https://doi.org/10.1007/s11136-020-02545-y. Amirabadi, F., Saravani, S., Miri-Aliabad, G., Khorashadi-Zadeh, M. (2019). 'The Association between Dental Health Status and Oral Health-Related Quality of Life of Children Diagnosed with β-Thalassemia Major in Zahedan City, Iran', Journal of Pediatric Perspectives, 7(2), pp. 8985-8991. doi: 10.22038/ijp.2018.34517.3034 Barriault, S., Deneault, A.-A., Kempe, S., Madigan, S., Lovegrove, A., Dimitropoulos, G., Pillai Riddell, R. and Racine, N. (2019) 'A randomized waitlist control trial of the Make the Connection® online program for caregivers of infants and young children: Study protocol', BMC Pediatrics, 19, p. 176. https://doi.org/10.1186/s12887-019-1567-2 Desveaux, L., Agarwal, P., Shaw, J., Hensel, J.M., Mukerji, G., Onabajo, N., Marani, H., Jamieson, T., Bhattacharyya, O., Martin, D., Mamdani, M., Jeffs, L., Wodchis, W.P., Ivers, N.M. and Bhatia, R.S. (2018) 'A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol', BMC Medical Informatics and Decision Making, 18, Article 49. https://doi.org/10.1186/s12911-018-0613-5 El-Kamah, G., Adam, S., Magdy, P., Michel, M. and Afifi, H. (2014) 'Quality of life outcomes among Egyptian children with beta-thalassemia', Blood, 124(21), p. 4864. Fadel, H.T., Zolaly, M.A., Alharbi, M.O., Qarah, L.A., Alrehili, M.S., Alamri, A.D. and Tarawah, A.M. (2
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Oral Health Educational Program on Oral Hygiene and Oral Health Related Quality of Life in Children With β-Thalassemia Major: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07614217
- Acronym / sponsor ID
- OHRQOL in β-TM children
- Conditions
- B Thalassemia Major
- Keywords
- oral health related quality of life, oral health status, Beta Thalassemia Major children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 May 2026 (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.
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.
Detailed description
Benefits to the patient
- The clinical examination and OHRQoL assessments provide a well-established foundation to plan the oral-dental treatment for each individual.
- Improved awareness among β-thalassemia patients and caregivers regarding oral hygiene practices and the importance of regular dental visits may contribute to better oral health outcomes and enhanced overall quality of life.
Benefits to the community
- Provide valuable epidemiological data on the oral health status and oral health-related quality of life in children with β-thalassemia.
- Assist dental professionals, healthcare providers, and policymakers in planning targeted preventive strategies and integrating oral health care into the comprehensive management of thalassemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be allocated into two groups: an immediate intervention group and a waitlist control group. Both groups will undergo baseline assessment. The intervention group will receive the structured oral health educational program, while the waitlist group will receive routine care. After 3 months, both groups will be reassessed. Subsequently, the educational program will be provided to the waitlist group to ensure ethical equity.
| Arm | Type | Receives |
|---|---|---|
| an Immediate Intervention Group | Experimental | Other: oral health educational program for Immediate Intervention Grouporal health educational program will be given to this group of patients |
| Waitlist Control Group | Placebo comparator | Other: routine oral hygiene instructionsroutine oral hygiene instructions will be given to this group of children |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children having medical records confirmed of β-thalassemia diagnosis.
- Age range between 8-10 years old.
- Have acceptable cooperation
Key exclusion criteria (3 listed)
- 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
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 program for Immediate Intervention GroupOral 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 | Other | an Immediate Intervention Group |
| routine oral hygiene instructionsUse toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean | Other | Waitlist Control Group |
Primary outcome
Oral Hygiene
Time frame: Baseline Measurement and After 1,3 and 6 months
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.
1 secondary outcome
Oral Health Related Quality Of Life (OHRQoL)
Time frame: Baseline and after 1,3 and 6 months
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 7 Oct 2026.
- BackgroundAbbas, F., Tabesh, A., Yavari, A., Makaremi, R., Bizhani, O. and Mahmood, M. (2023) 'Evaluation and relation of oral health-related quality of life and oral health status in Thalassemia Major patients, a cross-sectional study', BMC Oral Health, 23(493), pp. 1-9. Available at: doi.org. Al-Blaihed, D., El-Housseiny, A.A., Farsi, N.J. and Farsi, N.M. (2020) 'Validity and reliability of the Arabic version of the child perceptions questionnaire for 8-10-year-old children', Quality of Life Research, 29(11), pp. 3119-3125. Available at: https://doi.org/10.1007/s11136-020-02545-y. Amirabadi, F., Saravani, S., Miri-Aliabad, G., Khorashadi-Zadeh, M. (2019). 'The Association between Dental Health Status and Oral Health-Related Quality of Life of Children Diagnosed with β-Thalassemia Major in Zahedan City, Iran', Journal of Pediatric Perspectives, 7(2), pp. 8985-8991. doi: 10.22038/ijp.2018.34517.3034 Barriault, S., Deneault, A.-A., Kempe, S., Madigan, S., Lovegrove, A., Dimitropoulos, G., Pillai Riddell, R. and Racine, N. (2019) 'A randomized waitlist control trial of the Make the Connection® online program for caregivers of infants and young children: Study protocol', BMC Pediatrics, 19, p. 176. https://doi.org/10.1186/s12887-019-1567-2 Desveaux, L., Agarwal, P., Shaw, J., Hensel, J.M., Mukerji, G., Onabajo, N., Marani, H., Jamieson, T., Bhattacharyya, O., Martin, D., Mamdani, M., Jeffs, L., Wodchis, W.P., Ivers, N.M. and Bhatia, R.S. (2018) 'A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol', BMC Medical Informatics and Decision Making, 18, Article 49. https://doi.org/10.1186/s12911-018-0613-5 El-Kamah, G., Adam, S., Magdy, P., Michel, M. and Afifi, H. (2014) 'Quality of life outcomes among Egyptian children with beta-thalassemia', Blood, 124(21), p. 4864. Fadel, H.T., Zolaly, M.A., Alharbi, M.O., Qarah, L.A., Alrehili, M.S., Alamri, A.D. and Tarawah, A.M. (2
- Individual participant dataSharing planned: No
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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.
Mariam MohamedDia Shafie, Bachelor of Dental Surgery contact
Questions about this trial
What is this clinical trial studying?
A study testing oral health educational program for Immediate Intervention Group and routine oral hygiene instructions in people with B Thalassemia Major, run by Cairo University.
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 3 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Mariam MohamedDia Shafie, Bachelor of Dental Surgery (+01226602585, mariam.diaaeldin@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 Hygiene (time frame: Baseline Measurement and After 1,3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614217, which also lists 1 linked publication.
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 7 Oct 2026.