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Molar Incisor HypomineralizationNCT05809791

Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars

An observational study of Molar Incisor Hypomineralization, run by IRCCS Burlo Garofolo at 5 sites in 3 countries.

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

Molar and Incisor Hypomineralization (MIH) is a qualitative developmental defect of the dental enamel with a multifactorial aetiology defined in 2001 as an "hypomineralization of systemic origin affecting one or more permanent molars, usually first permanent molars (FPMs) with or without the involvement of one or more… Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Molar Incisor Hypomineralization
How many people
97 participants
Where
5 sitesin 3 countries
Study dates
2 Mar 2021to 31 Dec 2024
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 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Subjects will be selected among patients attending the involved Dental Clinics according to the following criteria

Who may be able to join

  • Age: 6-16 years;
  • Signature of the informed consent to the study by patients' parents or by their legal guardians

Who cannot join

  • Fluorosis, white spots, amelogenesis imperfecta, hypoplasia or other dental enamel defects in differential diagnosis with MIH and HSPM;
  • Patients not sufficiently cooperative;
  • Children with orthodontic devices hiding the teeth to consider

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Italy3 sites
  • IRCCS Burlo Garofolo

    Trieste, Italy, 34137

  • Maggiore Hospital

    Trieste, Trieste

  • IRCCS Burlo Garofolo

    Trieste, 34137

Other trials in Italy

Spain1 site
  • Servicio de Odontología de la Universidad de Zaragoza

    Huesca, Huesca

Other trials in Spain

Turkey (Türkiye)1 site
  • Faculty of Dentistry of the Yeditepe University

    Istanbul, Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence and Clinical Characteristics of Molar Incisor Hypomineralization (MIH) and Hypomineralized Second Primary Molars (HSPM) Among Italian, Spanish and Turkish Children: a Multicenter Epidemiological Study

Molar and Incisor Hypomineralization (MIH) is a qualitative developmental defect of the dental enamel with a multifactorial aetiology defined in 2001 as an "hypomineralization of systemic origin affecting one or more permanent molars, usually first permanent molars (FPMs) with or without the involvement of one or more affected permanent incisors". Due to its porous structure with an altered prism organization and an increased content of proteins, the hypomineralized enamel has reduced mechanical properties and a lower refractive index in comparison to the sound enamel. MIH is associated to a large number of objective and subjective problems as an altered aesthetics, an increased risk of plaque accumulation, caries and/or post-eruptive breakdown, reduced retention rates of adhesive materials, hypersensitivity and difficulty in anesthetizing the affected teeth that make its management a challenging condition. MIH is a very widespread pathology with a worldwide prevalence ranging from 2.8 to 44% and a global average prevalence of 13.1% with significant geographical differences. In 2015, the number of global prevalent cases was estimated at 878 million people with a percentage of needing-care cases of 27.4% (in mean 240 million prevalent cases). In Europe, MIH prevalence rates between 3.6 to 25%. Regarding Italy, a limited number of prevalence studies are available. Recently, literature reports that the presence of MIH-like lesions in primary dentition, especially on second primary molars, may be a predictive factor for developing MIH in permanent dentition. However, the absence of this defect called Hypomineralized Second Primary Molars (HSPM) does not rule out MIH development. The early diagnosis of HSPM is very useful to early diagnose MIH and reduce its care burden. The reported HSPM global prevalence rate ranges from 0 to 21.8% with a global average about 7.88%. MIH and HSPM are both very widespread pathologies affecting an increasing number of children worldwide and represent a significant problem in pediatric dentistry. The aim of this study is to estimate the prevalence of MIH in Italian (Trieste), Spanish (Huesca, Zaragoza) and Turkish (Istanbul) children. The hypothesis is that the estimated prevalence of MIH may be in line with that reported in literature and that the presence of HSPM in primary dentition may be associated with MIH development in permanent dentition.

Keywords
Molar Incisor Hypomineralization (MIH), Hypomineralized Second Primary Molars (HSPM), Prevalence
Medical subject headings
Molar Hypomineralization

What is being measured

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

  1. MIH prevalence rate

    Prevalence of the condition in the populations studied

    Measured: At baseline (day one)

Secondary outcomes (4)
  1. Description of MIH clinical characteristics

    Description of the clinical characteristics of MIH, evaluated by questionnaire

    Measured: At baseline (day one)

  2. Frequency of the most frequently affected teeth

    Evaluated by questionnaire

    Measured: At baseline (day one)

  3. Association between HSPM and MIH development

    Evaluated by questionnaire

    Measured: At baseline (day one)

  4. Association between MIH/HSPM and presence of caries

    Evaluated by questionnaire

    Measured: At baseline (day one)

Timeline

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

  1. First posted12 Apr 2023
  2. Study start2 Mar 2021
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

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
Other
Time perspective
Cross-sectional
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05809791
Sponsor's protocol ID
RC 11/21
Status last verified
May 2025
First submitted
28 Mar 2023
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Molar Incisor Hypomineralization, run by IRCCS Burlo Garofolo at 5 sites in 3 countries.

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 2 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, Spain, Turkey (Türkiye). 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?

MIH prevalence rate (time frame: At baseline (day one)). 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 16 May 2025.

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