Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars

NCT05809791 | Completed

• 1 other identifier: RC 11/21
• Study Type: observational
• Target: 97
• Locations: 3 countries
• Sites: 5

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• MIH prevalence rate

  Prevalence of the condition in the populations studied

  At baseline (day one)

Secondary Outcomes (4)

• Description of MIH clinical characteristics

  At baseline (day one)

• Frequency of the most frequently affected teeth

  At baseline (day one)

• Association between HSPM and MIH development

  At baseline (day one)

• Association between MIH/HSPM and presence of caries

  At baseline (day one)

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (5)

IRCCS Burlo Garofolo

Trieste, Italy, 34137, Italy

Location

Maggiore Hospital

Trieste, Trieste, Italy

Location

IRCCS Burlo Garofolo

Trieste, 34137, Italy

Location

Servicio de Odontología de la Universidad de Zaragoza

Huesca, Huesca, Spain

Location

Faculty of Dentistry of the Yeditepe University

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Milena Cadenaro, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 12, 2023
• Study Start: March 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (3); TU (1)