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.
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
Spain1 site
Servicio de Odontología de la Universidad de Zaragoza
Huesca, Huesca
Turkey (Türkiye)1 site
Faculty of Dentistry of the Yeditepe University
Istanbul, Istanbul
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.
- Conditions
- Molar Incisor Hypomineralization
- 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.
MIH prevalence rate
Prevalence of the condition in the populations studied
Measured: At baseline (day one)
Secondary outcomes (4)
Description of MIH clinical characteristics
Description of the clinical characteristics of MIH, evaluated by questionnaire
Measured: At baseline (day one)
Frequency of the most frequently affected teeth
Evaluated by questionnaire
Measured: At baseline (day one)
Association between HSPM and MIH development
Evaluated by questionnaire
Measured: At baseline (day one)
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.
- First posted12 Apr 2023
- Study start2 Mar 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milena Cadenaro, MD, Study director, IRCCS materno infantile Burlo Garofolo
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05809791
- Acronym / sponsor ID
- RC 11/21
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization (MIH), Hypomineralized Second Primary Molars (HSPM), Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Apr 2023 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be selected among patients attending the involved Dental Clinics according to the following criteria
Key inclusion criteria (2 listed)
- Age: 6-16 years;
- Signature of the informed consent to the study by patients' parents or by their legal guardians
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MIH prevalence rate
Time frame: At baseline (day one)
Prevalence of the condition in the populations studied
4 secondary outcomes
Description of MIH clinical characteristics
Time frame: At baseline (day one)
Frequency of the most frequently affected teeth
Time frame: At baseline (day one)
Association between HSPM and MIH development
Time frame: At baseline (day one)
Association between MIH/HSPM and presence of caries
Time frame: At baseline (day one)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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. This study is not recruiting at the moment.
Milena Cadenaro, MD study director
IRCCS materno infantile Burlo Garofolo
5 sites in 3 countries: see every site and its status.
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.