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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Hypomineralization of Enamel; Dental Fear
• Intervention / Treatment: Procedure: Extraction therapy; Procedure: Restorative therapy

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 Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Extraction therapy; Extraction treatment of first permanent molars affected with severe MIH
Experimental: 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.	Procedure: Restorative therapy; Restorative treatment of first permanent molars affected with severe MIH
Experimental: 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.	Procedure: Extraction therapy; Extraction treatment of first permanent molars affected with severe MIH; Procedure: Restorative therapy; Restorative treatment of first permanent molars affected with severe MIH
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental fear and anxiety	Questionnaire: Children's Fear Survey Schedule - Dental Subscale (CFSS-DS). Range 15-75, lower score indicated lower 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))
Oral helth-related quality of life	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	At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))
Health economics	Journal extract: nummber of dental visits and the length of dental visits. More dental chairtime indicates a higher health economic impact.	At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region; Region Östergötland; Malmö University
• Investigators: Principal Investigator: Agneta Robertson, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 31, 2020
• Study Completion (Estimated): September 4, 2028

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 276481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As soon as we finish with the data collection and the manuscript writing, the data will be published online.
• IPD Sharing Time Frame: After 2028
• IPD Sharing Access Criteria: The data will be de-identified
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No