Hypomineralization of EnamelGuREx-MIHNCT06228989
Analysis of Treatment Outcomes in Patients Affected by Molar-Incisor Hypomineralization (MIH)
A study testing Restorative therapy and Extraction therapy in people with Hypomineralization of Enamel and Dental Fear, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization of Enamel, Dental Fear, Quality of Life
- What is being tested?
- Restorative therapy and Extraction therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 4 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-9 years
- Diagnosed with at least one first permanent molar with MIH defree 4-6
Who cannot join
- Dental agenesis
- General disorders, including chronic diseases and functional limitations
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypomineralization of Enamel, Dental Fear, Quality of Life
- Being tested
- Restorative therapy, Extraction therapy
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative therapyProcedure or surgery
Restorative treatment of first permanent molars affected with severe MIH
Extraction therapyProcedure or surgery
Extraction treatment of first permanent molars affected with severe MIH
| Study group | Role | What they receive |
|---|---|---|
| Extraction therapy | Experimental | 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. Receives: Procedure: Extraction therapy |
| Restorative therapy | Experimental | 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. Receives: Procedure: Restorative therapy |
| Extraction therapy and Restorative therapy | Experimental | 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. Receives: Procedure: Restorative therapy; Procedure: Extraction therapy |
| Control patients | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Jan 2016
- Primary completion31 Jan 2020
- Study completion4 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypomineralization of EnamelStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Region Östergötland, Malmö University
- Responsible party
- Sponsor
- Investigators
- Agneta Robertson, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228989
- Sponsor's protocol ID
- 276481
- Acronym
- GuREx-MIH
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As soon as we finish with the data collection and the manuscript writing, the data will be published online.
Publications
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.
PubMed 41527098
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration or Extraction as Dental Therapy in First Permanent Molars With Severe Hypomineralized Enamel (MIH) - a National Randomized Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06228989
- Acronym / sponsor ID
- GuREx-MIH / 276481
- Conditions
- Hypomineralization of Enamel, Dental Fear, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Region Östergötland, Malmö University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 4 Sep 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A multicentre prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Extraction therapy | Experimental | Procedure: Extraction therapyPatients 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. |
| Restorative therapy | Experimental | Procedure: Restorative therapyPatients 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 | Experimental | Procedure: Restorative therapy, Procedure: Extraction therapyPatients 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. |
| Control patients | No intervention | –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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-9 years
- Diagnosed with at least one first permanent molar with MIH defree 4-6
Key exclusion criteria (2 listed)
- Dental agenesis
- General disorders, including chronic diseases and functional limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorative therapyRestorative treatment of first permanent molars affected with severe MIH | Procedure or surgery | Extraction therapy and Restorative therapy, Restorative therapy |
| Extraction therapyExtraction treatment of first permanent molars affected with severe MIH | Procedure or surgery | Extraction therapy, Extraction therapy and Restorative therapy |
Primary outcome
Dental fear and anxiety
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 41527098Hajdarevic 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.
- Individual participant dataSharing planned: Yes. As soon as we finish with the data collection and the manuscript writing, the data will be published online.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agneta Robertson principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing Restorative therapy and Extraction therapy in people with Hypomineralization of Enamel and Dental Fear, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental fear and anxiety (time frame: At baseline - age 6-9 years (T0), At 1st follow-up - age 11 years (T1), At 2nd follow-up - age 15 years (T2))). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.