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

NCT ID: NCT06228989

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2028-09-04

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.

Conditions

Hypomineralization of Enamel; Dental Fear; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extraction therapy

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.

Group Type: EXPERIMENTAL

Extraction therapy

Intervention Type: PROCEDURE

Extraction treatment of first permanent molars affected with severe MIH

Restorative therapy

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.

Group Type: EXPERIMENTAL

Restorative therapy

Intervention Type: PROCEDURE

Restorative treatment of first permanent molars affected with severe MIH

Extraction therapy and Restorative therapy

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.

Group Type: EXPERIMENTAL

Restorative therapy

Intervention Type: PROCEDURE

Restorative treatment of first permanent molars affected with severe MIH

Extraction therapy

Intervention Type: PROCEDURE

Extraction treatment of first permanent molars affected with severe MIH

Control patients

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Restorative therapy

Restorative treatment of first permanent molars affected with severe MIH

Intervention Type: PROCEDURE

Extraction therapy

Extraction treatment of first permanent molars affected with severe MIH

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Region Östergötland

OTHER

Sponsor Role: collaborator

Malmö University

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agneta Robertson

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Other Identifiers

276481

Identifier Type: -

Identifier Source: org_study_id