GuREx-MIH
Restoration or Extraction as Dental Therapy in First Permanent Molars With Severe Hypomineralized Enamel (MIH) - a National Randomized Prospective Multicenter Study
Sponsor study identifier
interventional
282
0 countries
N/A
Study Start
January 1, 2016
Actual (reported)Primary Completion
January 31, 2020
Actual (reported)Study Completion
September 4, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 4, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2016
Actual (reported)January 31, 2020
Actual (reported)January 3, 2024
Actual (reported)January 29, 2024
Actual (reported)September 4, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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))
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.
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.
Restorative treatment of first permanent molars affected with severe MIH
Extraction treatment of first permanent molars affected with severe MIH
Hajdarevic A, Cirgic E, Jalevik B, Robertson A, Fagrell T, Svensson M, Sabel N. 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. BMC Oral Health. 2026 Jan 12;26(1):126. doi: 10.1186/s12903-025-07633-4.
Agneta Robertson
Göteborg University
282 participants (actual enrollment reported by the registry).
First Submitted
January 3, 2024
First Posted
January 29, 2024
Study Start
January 1, 2016
Actual (reported)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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 31, 2020
Actual (reported)Study Completion
September 4, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 29, 2024
Record last verified: 2024-01
As soon as we finish with the data collection and the manuscript writing, the data will be published online.
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Source: ClinicalTrials.gov.
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