NCT04344340

Brief Summary

Aim of the Study Evaluate association between HSPM and MIH in Egyptian children. Record the prevalence of HSPM and MIH in Egyptian children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

March 6, 2020

Last Update Submit

January 23, 2023

Conditions

Hypomineralization of EnamelHypomineralization Molar Incisor

Keywords

HSPM & MIH

Outcome Measures

Primary Outcomes (1)

  • The prevalence of hypomineralized second primary molars.

    The percentage of children who has enamel defect on their second primary molars in the study

    1 year

Secondary Outcomes (1)

  • the prevalence of Molar Incisor Hypomineralization

    1 year

Interventions

clinical examinationDIAGNOSTIC_TEST

clinical examination

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children aged from 8 to 9 years attending outpatient clinic in Pediatric Dentistry Department, Faculty of Dentistry, Cairo University will be included in this study according to eligibility criteria

You may qualify if:

  • Children aged from 8 to 9 years.
  • Both genders.
  • No systemic health problems

You may not qualify if:

  • Children with extracted primary second molars and permanent incisors and molars.
  • Children with history of dental trauma.
  • Children with orthodontic bands or dental appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 11562, Egypt

Location

Related Publications (16)

  • Broadbent JM, Thomson WM, Williams SM. Does caries in primary teeth predict enamel defects in permanent teeth? A longitudinal study. J Dent Res. 2005 Mar;84(3):260-4. doi: 10.1177/154405910508400310.

    PMID: 15723867BACKGROUND

  • Elfrink ME, ten Cate JM, Jaddoe VW, Hofman A, Moll HA, Veerkamp JS. Deciduous molar hypomineralization and molar incisor hypomineralization. J Dent Res. 2012 Jun;91(6):551-5. doi: 10.1177/0022034512440450. Epub 2012 Feb 27.

    PMID: 22370445BACKGROUND

  • Elfrink ME, Schuller AA, Weerheijm KL, Veerkamp JS. Hypomineralized second primary molars: prevalence data in Dutch 5-year-olds. Caries Res. 2008;42(4):282-5. doi: 10.1159/000135674. Epub 2008 Jun 4.

    PMID: 18523388BACKGROUND

  • Elfrink ME, Ghanim A, Manton DJ, Weerheijm KL. Standardised studies on Molar Incisor Hypomineralisation (MIH) and Hypomineralised Second Primary Molars (HSPM): a need. Eur Arch Paediatr Dent. 2015 Jun;16(3):247-55. doi: 10.1007/s40368-015-0179-7. Epub 2015 Apr 18.

    PMID: 25894247BACKGROUND

  • Garot E, Denis A, Delbos Y, Manton D, Silva M, Rouas P. Are hypomineralised lesions on second primary molars (HSPM) a predictive sign of molar incisor hypomineralisation (MIH)? A systematic review and a meta-analysis. J Dent. 2018 May;72:8-13. doi: 10.1016/j.jdent.2018.03.005. Epub 2018 Mar 14.

    PMID: 29550493BACKGROUND

  • Ghanim A, Manton D, Marino R, Morgan M, Bailey D. Prevalence of demarcated hypomineralisation defects in second primary molars in Iraqi children. Int J Paediatr Dent. 2013 Jan;23(1):48-55. doi: 10.1111/j.1365-263X.2012.01223.x. Epub 2012 Jan 25.

    PMID: 22276809BACKGROUND

  • Ghanim A, Elfrink M, Weerheijm K, Marino R, Manton D. A practical method for use in epidemiological studies on enamel hypomineralisation. Eur Arch Paediatr Dent. 2015 Jun;16(3):235-46. doi: 10.1007/s40368-015-0178-8. Epub 2015 Apr 28.

    PMID: 25916282BACKGROUND

  • Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.

    PMID: 28721667BACKGROUND

  • Leppaniemi A, Lukinmaa PL, Alaluusua S. Nonfluoride hypomineralizations in the permanent first molars and their impact on the treatment need. Caries Res. 2001 Jan-Feb;35(1):36-40. doi: 10.1159/000047428.

    PMID: 11125194BACKGROUND

  • Lygidakis NA, Dimou G, Marinou D. Molar-incisor-hypomineralisation (MIH). A retrospective clinical study in Greek children. II. Possible medical aetiological factors. Eur Arch Paediatr Dent. 2008 Dec;9(4):207-17. doi: 10.1007/BF03262637.

    PMID: 19054474BACKGROUND

  • Negre-Barber A, Montiel-Company JM, Boronat-Catala M, Catala-Pizarro M, Almerich-Silla JM. Hypomineralized Second Primary Molars as Predictor of Molar Incisor Hypomineralization. Sci Rep. 2016 Aug 25;6:31929. doi: 10.1038/srep31929.

    PMID: 27558479BACKGROUND

  • Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.

    PMID: 11641576BACKGROUND

  • Weerheijm KL, Mejare I. Molar incisor hypomineralization: a questionnaire inventory of its occurrence in member countries of the European Academy of Paediatric Dentistry (EAPD). Int J Paediatr Dent. 2003 Nov;13(6):411-6. doi: 10.1046/j.1365-263x.2003.00498.x.

    PMID: 14984047BACKGROUND

  • Butler PM. Comparison of the development of the second deciduous molar and first permanent molar in man. Arch Oral Biol. 1967 Nov;12(11):1245-60. doi: 10.1016/0003-9969(67)90126-4. No abstract available.

    PMID: 5234231BACKGROUND

  • Whatling R, Fearne JM. Molar incisor hypomineralization: a study of aetiological factors in a group of UK children. Int J Paediatr Dent. 2008 May;18(3):155-62. doi: 10.1111/j.1365-263X.2007.00901.x.

    PMID: 18384347BACKGROUND

  • Small BW, Murray JJ. Enamel opacities: prevalence, classifications and aetiological considerations. J Dent. 1978 Mar;6(1):33-42. doi: 10.1016/0300-5712(78)90004-0. No abstract available.

    PMID: 275292BACKGROUND

MeSH Terms

Conditions

Dental Enamel HypomineralizationMolar Hypomineralization

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rania A Taha, Professor

    Cairo U

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle invistigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

April 14, 2020

Study Start

June 1, 2021

Primary Completion

December 30, 2021

Study Completion

March 1, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

EG(1)