CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,279 enrolled
Drug / intervention
This is a non intervention - observation only studyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05812690
NCT05812690N/ACompleted

An International Study of Molar Incisor Hypomineralisation and Its Association With Dental Anomalies

Sheffield Teaching Hospitals NHS Foundation Trust·observational·Posted Apr 14, 2023·Updated Aug 21, 2024

In Brief

An observational study evaluating This is a non intervention - observation only study for Molar Incisor Hypomineralisation. Completed, enrolled 1,279 participants across 1 site.

Detailed Summary

Background/study aim: Molar incisor hypomineralisation (MIH) is a common disorder of tooth development. Affected teeth have weak enamel and adult molars often require extensive treatment or even extraction. A preliminary study, carried out in Sheffield Dental Hospital, discovered that 12% of MIH children also had congenitally missing adult teeth, presenting further challenges to treatment-planning. This novel finding stimulated discussion between international MIH experts; whilst some clinicians had observed this association, others had not. Therefore the primary aim of this international study is to determine the association between MIH and missing teeth in different populations. This has important clinical and biological relevance in understanding the presentation and management of MIH. Participants/research sites: This study will include 584 children with MIH and a comparison group of 584 children without MIH. Young dental patients, aged 7-16 years, who attend for a check-up or treatment at one of the 15 participating countries will be invited to take part. The UK sites are Sheffield, Newcastle and University College London Dental Hospitals and all children will be seen by specialists/consultants in paediatric dentistry to confirm their diagnosis of MIH. The main inclusion criteria is that children have a dental xray as part of their routine care. Data collection: Following a routine dental check-up we will grade the severity of the participants' MIH (if present) and record any other dental anomalies (e.g. abnormal tooth number, position or shape). We will also check the dental xray for other anomalies that cannot be seen from the clinical exam. We will analyse the prevalence of MIH and association with other dental anomalies to see if there are difference according to sex or ethnicity and compare our findings with the non-MIH group. We anticipate the study will take 18 months.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 14, 2023
Enrollment StartNov 29, 2022
Primary CompletionAug 22, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

This is a non intervention - observation only studyother

This is non intervention study