Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars

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.

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34137
    • IRCCS Burlo Garofolo
  • Trieste, Italy
    • Maggiore Hospital
• Spain
  • Huesca, Spain
    • Servicio de Odontología de la Universidad de Zaragoza
• Turkey
  • Istanbul, Turkey
    • Faculty of Dentistry of the Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIH prevalence rate	Prevalence of the condition in the populations studied	At baseline (day one)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of MIH clinical characteristics	Description of the clinical characteristics of MIH, evaluated by questionnaire	At baseline (day one)
Frequency of the most frequently affected teeth	Evaluated by questionnaire	At baseline (day one)
Association between HSPM and MIH development	Evaluated by questionnaire	At baseline (day one)
Association between MIH/HSPM and presence of caries	Evaluated by questionnaire	At baseline (day one)

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Milena Cadenaro, MD, IRCCS Materno Infantile Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prevalence; Molar Incisor Hypomineralization (MIH); Hypomineralized Second Primary Molars (HSPM)
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Tooth Abnormalities; Molar Hypomineralization; Dental Enamel Hypoplasia
• Other Study ID Numbers: RC 11/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No