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Hypomineralization of EnamelNCT04344340

The Association Between MIH and HSPM

An observational study of Hypomineralization of Enamel and Hypomineralization Molar Incisor, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim of the Study Evaluate association between HSPM and MIH in Egyptian children. Record the prevalence of HSPM and MIH in Egyptian children Read more about this study

Who is it for?
Ages 8 to 9 years
What is being tested?
clinical examination
How many people
190 participants
Where
1 siteEgypt
Study dates
1 Jun 2021to 1 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

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 9 years
  • All sexes
  • Child

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Cairo University

    Cairo, Giza Governorate, 11562

Other trials in Egypt

About this study

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

Read the detailed description

Statement of the Problem:

Molar Incisor Hypomineralization (MIH) is defined as developmental qualitative defect of systemic origin, which affects one to four of first permanent molars and frequently associated with permanent incisors . The prevalence of MIH worldwide was reported from 2.4% to40.2% and clinical measures of MIH based on scientific criteria was established based on the European Academy of Pediatric Dentistry criteria to allow comparison between the findings of different studies .

The most commonly reported clinical problems for patients with MIH are hypersensitivity of teeth to various thermal and mechanical stimuli result in improper tooth brushing, plaque accumulation and rapid caries progression. Severely affected enamel shows post eruptive breakdown and such teeth require extensive treatment, ranging from prevention to restorations and extractions. MIH patients also have increased risk of developing dental fear and anxiety as well as behavior management problems added to the difficulty to achieve effective local anaesthesia which are related to chronic pulp inflammation from dentin exposure due to excessive enamel breakdown.

Rational As developmental of Second Primary Molar start at the same time as the development of the first permanent molars and incisor but the maturation of permanent teeth occur more slow. So when a systemic disturbance occur it affect second primary molar as well as first permanent molar and incisors.

Few studies test the association between hypomineralized second primary molar (HSPM) and MIH. While no study available on Egyptian children.

Being tested
clinical examination
Keywords
HSPM & MIH
Medical subject headings
Dental Enamel Hypomineralization, Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical examinationDiagnostic test

    clinical examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of hypomineralized second primary molars.

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

    Measured: 1 year

Secondary outcomes (1)

  1. the prevalence of Molar Incisor Hypomineralization

    The percentage of children who has enamel defect on their permenant molars and Incisors at this study

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start1 Jun 2021
  3. Primary completion30 Dec 2021
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04344340
Sponsor's protocol ID
MIH and HSPM
Status last verified
Jan 2023
First submitted
6 Mar 2020
Last updated
25 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15723867

  • 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.

    PubMed 22370445

  • 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.

    PubMed 18523388

  • 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.

    PubMed 25894247

  • 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.

    PubMed 29550493

  • 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.

    PubMed 22276809

  • 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.

    PubMed 25916282

  • 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.

    PubMed 28721667

  • 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.

    PubMed 11125194

  • 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.

    PubMed 19054474

  • 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.

    PubMed 27558479

  • 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.

    PubMed 11641576

  • 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.

    PubMed 14984047

  • 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.

    PubMed 5234231

  • 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.

    PubMed 18384347

Questions about this trial

What is this clinical trial studying?

An observational study of Hypomineralization of Enamel and Hypomineralization Molar Incisor, 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 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: finished, as of the sponsor's last update on 25 Jan 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of hypomineralized second primary molars. (time frame: 1 year). 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 NCT04344340, which also lists 16 linked publications.

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 25 Jan 2023.

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