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

Quality of Life Clinical Trial

— GuREx-MIH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06228989
• Other study ID #: 276481
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: September 4, 2028

Study information

• Verified date: January 2024
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 282
• Est. completion date: September 4, 2028
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Fear
• Hypomineralization of Enamel
• Quality of Life

Intervention

Procedure:
• Restorative therapy
Restorative treatment of first permanent molars affected with severe MIH
• Extraction therapy
Extraction treatment of first permanent molars affected with severe MIH

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Göteborg University	Malmö University, Region Östergötland, Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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))
Primary	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))