Skip to content

Analysis of Treatment Outcomes in Patients Affected by Molar-Incisor Hypomineralization (MIH)

Restoration or Extraction as Dental Therapy in First Permanent Molars With Severe Hypomineralized Enamel (MIH) - a National Randomized Prospective Multicenter Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06228989
Acronym
GuREx-MIH
Enrollment
282
Registered
2024-01-29
Start date
2016-01-01
Completion date
2028-09-04
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Fear, Hypomineralization of Enamel, Quality of Life

Brief summary

The aim is to long-term evaluate extraction or restoration therapy, of first permanent molars with extensive treatment needs as a result of severe MIH in a national multicenter study concerning dental fear and anxiety, oral health-related quality of life, jaw development, and health economics.

Detailed description

First permanent molars often show areas of porous and hypomineralized enamel. This manifests itself clinically as whitish-yellow to brownish well-defined spots and, in severe disorders, disintegration of enamel. One to all molars are affected and at the same time, the permanent incisors may show opacities. The condition is called Molar-Incisor Hypomineralization (MIH) and occurs in 14% of children globally. Affected teeth create problems for the individual. The teeth are often painful, e.g. when brushing teeth, cold food/drink, or even when inhaling cold air. Dental treatment can be painful because it is difficult to get adequate anesthesia, probably due to subclinical pulp inflammation caused by the porosity of the enamel. Molars with severely demineralized enamel need dental care shortly after they have erupted due to decay and subsequent caries. 9-year-old children with severe MIH had their PFM treated almost ten times as often as a healthy control group. In case of widespread decay and hypersensitivity, extraction may be a treatment option. Two retrospective studies dealing with the extraction of first permanent molars due to MIH have been published: one study found that 87% showed acceptable gap closure and another study showed that 3 of 27 extraction cases had an objective need and only one case had a subjective need for orthodontic gap closure after the extraction. A review article discusses the scientific basis for treating severe first permanent molar due to severe MIH, and the author claims that both the profession and the public today believe in a more conservative restorative treatment. However, he states that there is a need for well-controlled long-term studies. The aim is to long-term evaluate extraction or restoration therapy, of first permanent molars with extensive treatment needs as a result of severe MIH in a national multicenter study concerning dental fear and anxiety, oral health-related quality of life, jaw development, and health economics.

Interventions

PROCEDURERestorative therapy

Restorative treatment of first permanent molars affected with severe MIH

PROCEDUREExtraction therapy

Extraction treatment of first permanent molars affected with severe MIH

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Region Östergötland
CollaboratorOTHER
Malmö University
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A multicentre prospective randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 6-9 years * Diagnosed with at least one first permanent molar with MIH defree 4-6

Exclusion criteria

* Dental agenesis * General disorders, including chronic diseases and functional limitations

Design outcomes

Primary

MeasureTime frameDescription
Dental fear and anxietyAt baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))Questionnaire: Children's Fear Survey Schedule - Dental Subscale (CFSS-DS). Range 15-75, lower score indicated lower dental fear and anxiety
Oral helth-related quality of lifeAt baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))Questionnaire: Short form of Child Perceptions Questionnaire for 11-14-year-old children (CPQ11-14). Range 0-64, lower score indicated better oral helth-related quality of life
Health economicsAt baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))Journal extract: nummber of dental visits and the length of dental visits. More dental chairtime indicates a higher health economic impact.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026