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Oral Health Status in Children With β-Thalassemia Major

25. maj 2026 opdateret af: Mariam Mohamed Mohamed Diaa eldin Shafie, Cairo University

Effectiveness of a Structured Oral Health Educational Program on Oral Hygiene and Oral Health Related Quality of Life in Children With β-Thalassemia Major: Before and After Interventional Study.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Children having medical records confirmed of β-thalassemia diagnosis.
  • Age range between 8-10 years old.
  • Have acceptable cooperation

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: an Immediate Intervention Group
oral health educational program will be given to this group of patients
Andet: oral health educational program for Immediate Intervention Group

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
Placebo komparator: Waitlist Control Group
routine oral hygiene instructions will be given to this group of children
Andet: routine oral hygiene instructions
Use toothbrush and toothpaste for oral hygiene Brush twice daily Regular dental checkups Keep toothbrush clean

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oral Hygiene
Tidsramme: 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.
Baseline Measurement and After 1,3 and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oral Health Related Quality Of Life (OHRQoL)
Tidsramme: Baseline and after 1,3 and 6 months

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.
Baseline and after 1,3 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • OHRQOL in β-TM children

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med B Thalassemia Major

Kliniske forsøg med oral health educational program for Immediate Intervention Group

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