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

Not Applicable

Active, not recruiting

• Conditions: Dental Fear; Quality of Life; Hypomineralization of Enamel
• Interventions: Procedure: Restorative therapy; Procedure: Extraction therapy

• Registration Number: NCT06228989
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-01-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Completion: 2028-09-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restorative therapy	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.
Extraction therapy and Restorative therapy	Extraction 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.
Extraction therapy and Restorative therapy	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.
Extraction therapy	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.

Primary Outcome Measures

Name	Time	Method
Dental fear and anxiety	At 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 life	At 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 economics	At 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.