NCT06228989: GuREx-MIH

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

Active, enrolled NA Last updated 29 January 2024

What this trial tests

NA trial testing Restorative therapy in Hypomineralization of Enamel in 282 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2016

Primary endpoint
31 January 2020

4 September 2028

Quick facts

Lead sponsor	Göteborg University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	282
Start date	1 January 2016
Primary completion	31 January 2020
Estimated completion	4 September 2028

Drugs / interventions tested

• Restorative therapy
• Extraction therapy

Conditions studied

• Hypomineralization of Enamel — all drugs for Hypomineralization of Enamel →
• Dental Fear — all drugs for Dental Fear →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Göteborg University

Who can join

Adults 6 to 9, any sex, with Hypomineralization of Enamel or Dental Fear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of molar incisor hypomineralization on oral health-related quality of life, dental fear and anxiety in Swedish children.
   Hajdarević A, Jälevik B, Čirgić E, Robertson A, et al · · 2025 · cited 3× · PMID 40497415 · DOI 10.2340/aos.v84.43856
2. GuREx-MIH: radiographic assessment of eruption patterns of second permanent molars and premolars in 11-year-olds after early extraction of the first permanent molar - a split-mouth trial.
   Hajdarević A, Stervik C, Sabel N, Jälevik B, et al · · 2025 · cited 2× · PMID 40810339 · DOI 10.1093/ejo/cjaf055
3. GuREx-MIH: cost-effectiveness analysis of extraction versus restorative treatment for first permanent molars affected by Molar-Incisor Hypomineralisation in 11-year-old Swedish children.
   Hajdarević A, Čirgić E, Jälevik B, Robertson A, et al · · 2026 · PMID 41527098 · DOI 10.1186/s12903-025-07633-4