Clinical trial NCT05809791: Molar Incisor Hypomineralization and Hypomineralized Second Primary Molars
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar Incisor Hypomineralization
Keywords: Molar Incisor Hypomineralization (MIH)
Hypomineralized Second Primary Molars (HSPM)
Prevalence
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 97
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected among patients attending the involved Dental Clinics according to the following criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: MIH prevalence rate
timeFrame: At baseline (day one)
Secondary outcomes:
measure: Description of MIH clinical characteristics
timeFrame: At baseline (day one)
measure: Frequency of the most frequently affected teeth
timeFrame: At baseline (day one)
measure: Association between HSPM and MIH development
timeFrame: At baseline (day one)
measure: Association between MIH/HSPM and presence of caries
timeFrame: At baseline (day one)
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
city: Trieste
country: Italy
facility: Maggiore Hospital
city: Huesca
country: Spain
facility: Servicio de Odontología de la Universidad de Zaragoza
city: Istanbul
country: Turkey
facility: Faculty of Dentistry of the Yeditepe University
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Milena Cadenaro, MD
role: STUDY_DIRECTOR
References: