Molar Incisor Hypomineralisation and Dental Anomalies

NCT05812690 | Completed

• 1 other identifier: STH21833
• Study Type: observational
• Target: 1,279
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molar Incisor Hypomineralisation

Keywords

Molar Incisor Hypomineralisation; Dental Anomalies; Children; Hypodontia

Outcome Measures

Primary Outcomes (1)

• Prevalence of a dental anomaly in children with and without MIH

  Presence of any dental anomaly (number, shape, eruption disturbance)

  recruitment until July 2023

Secondary Outcomes (1)

• Characteristics associated with presence of a dental anomaly in children with MIH

  recruitment until July 2023

Study Arms (2)

Children with molar incisor hypomineralisation

Children referred to the host centres with a clear diagnosis of MIH, as given by a specialist paediatric dentist

Other: This is a non intervention - observation only study

Children without molar incisor hypomineralisation

Children referred to the host centres with no evidence of MIH

Other: This is a non intervention - observation only study

Interventions

This is a non intervention - observation only study OTHER

This is non intervention study

Children with molar incisor hypomineralisation; Children without molar incisor hypomineralisation

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population is children referred to any of the participating paediatric dentistry clinics for assessment or treatment.

You may qualify if:

• No significant medical history (ASA ≤ 2), syndromic conditions, cleft lip and/or palate.
• Have an existing (full) pan-oral radiograph at recruitment or subsequently undergoes one for routine diagnostic purposes.
• Child able to accept detailed clinical examination, radiographs (and photographs).
• Parents and child able to consent/assent to participate in the study and have sufficient level of literacy/understanding to complete written consent forms (with support if necessary).
• Children referred to the host centre for the management of any dental condition other than MIH.

You may not qualify if:

• Children with an atypical pattern of dental caries/extraction in their first permanent molars such that a possible diagnosis of MIH could not be excluded (Ghanim et al., 2017, Ghanim et al., 2019).

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Charles Clifford Dental Hospital

Sheffield, S Yorks, S10 2TA, United Kingdom

Location

Related Publications (5)

• Walshaw EG, Noble F, Conville R, Anne Lawson J, Hasmun N, Rodd H. Molar incisor hypomineralisation and dental anomalies: A random or real association? Int J Paediatr Dent. 2020 May;30(3):342-348. doi: 10.1111/ipd.12601. Epub 2019 Dec 13.

  PMID: 31790155 BACKGROUND

• Baccetti T. A controlled study of associated dental anomalies. Angle Orthod. 1998 Jun;68(3):267-74. doi: 10.1043/0003-3219(1998)0682.3.CO;2.

  PMID: 9622764 BACKGROUND

• Brook AH. Variables and criteria in prevalence studies of dental anomalies of number, form and size. Community Dent Oral Epidemiol. 1975 Nov;3(6):288-93. doi: 10.1111/j.1600-0528.1975.tb00326.x.

  PMID: 1104248 BACKGROUND

• Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.

  PMID: 28721667 BACKGROUND

• Schwendicke F, Elhennawy K, Reda S, Bekes K, Manton DJ, Krois J. Global burden of molar incisor hypomineralization. J Dent. 2018 Jan;68:10-18. doi: 10.1016/j.jdent.2017.12.002. Epub 2017 Dec 6.

  PMID: 29221956 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization; Tooth Abnormalities; Anodontia

Condition Hierarchy (Ancestors)

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

Study Officials

• Helen Rodd, BDS PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: November 29, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)