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

G

Göteborg University

Status

Active, not recruiting

Conditions

Quality of Life
Hypomineralization of Enamel
Dental Fear

Treatments

Procedure: Restorative therapy
Procedure: Extraction therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06228989
276481

Details and patient eligibility

About

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.

Full 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.

Enrollment

282 patients

Sex

All

Ages

6 to 9 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

282 participants in 4 patient groups

Extraction therapy
Experimental group
Description:
Patients exclusive treated with extraction therapy of any first permanent molars due to severe MIH. Affected first permanent molars were dignosed with MIH degree 4-6.
Treatment:
Procedure: Extraction therapy
Restorative therapy
Experimental group
Description:
Patients exclusive treated with restorative therapy of any first permanent molars due to severe MIH. Affected first permanent molars were dignosed with MIH degree 4-5.
Treatment:
Procedure: Restorative therapy
Extraction therapy and Restorative therapy
Experimental group
Description:
Patients undergoing combined treatment of both extraction therapy and restorative therapy of their first permanent molars due to MIH. Affected first permanent molars treated with extraction therapy were dignosed with MIH degree 6. Affected first permanent molars treated with restorative therapy were dignosed with MIH degree 4-5.
Treatment:
Procedure: Extraction therapy
Procedure: Restorative therapy
Control patients
No Intervention group
Description:
Patients devoid of any enamel developmental defects, attending the Public Dental Service in Region Västra Götaland, constituted a basis for the control patients. These controls were matched in terms of gender, age, and socio-economic factors, with each study patient paired with seven potential control patients.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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