Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars

Molar Incisor Hypomineralization Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809791
• Other study ID #: RC 11/21
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2023
• Source: IRCCS Burlo Garofolo
• Contact: Milena Cadenaro, MD
• Phone: +390403785
• Email: milena.cadenaro[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 227
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MIH prevalence rate	Prevalence of the condition in the populations studied	At baseline (day one)
Secondary	Description of MIH clinical characteristics	Description of the clinical characteristics of MIH, evaluated by questionnaire	At baseline (day one)
Secondary	Frequency of the most frequently affected teeth	Evaluated by questionnaire	At baseline (day one)
Secondary	Association between HSPM and MIH development	Evaluated by questionnaire	At baseline (day one)
Secondary	Association between MIH/HSPM and presence of caries	Evaluated by questionnaire	At baseline (day one)