Molar Incisor HypomineralisationNCT07142629
Selective Versus Non-selective Caries Excavation in MIH Affected Teeth.
A study testing Selective caries removal and Non-Selective caries removal in people with Molar Incisor Hypomineralisation and Dental Caries, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Molar Incisor Hypomineralisation, Dental Caries
- What is being tested?
- Selective caries removal and Non-Selective caries removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2024to Aug 2026
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patient age \<13 years old
- Non -contributory medical history
- Molar affected with MIH as per EAPD diagnostic criteria (White, creamy, or yellow to brownish opacities greater than one millimeter with/without postoperative enamel breakdown).
- Deep caries extending\>= 2/3 of dentine but not exposing the pulp on the bitewing radiograph.
- The tooth should give positive response to cold sensibility testing.
- Clinical diagnosis of normal/ reversible pulpitis
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- The tooth is restorable, probing pocket depth and mobility are within normal limits.
- No signs of pulpal necrosis including sinus tract or swelling
- No radiographic evidence of periapical changes indicative of apical periodontitis.
Who cannot join
- Medically compromised patient.
- Non-restorable tooth.
- Clinical diagnosis of irreversible pulpitis.
- Signs of pulpal necrosis including sinus tract or swelling.
- Teeth indicated for extraction for orthodontic reasons.
- Uncooperative children who could not be treated under local anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Selective Versus Non-selective Caries Excavation in MIH Affected Teeth: A Randomized Clinical Trial
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.
Read the detailed description
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.Cases will be collected from the undergraduate and postgraduate clinics over a 6 months\' period according to predetermined inclusion criteria. Preoperative clinical and radiographic assessment will be conducted to MIH affected molars. MIH molars with deep caries (assymptomatic/ with symptoms of reversible pulpitis) will be randomly allocated for the choice of treatment with selective or non -selective caries excavation. Randomization of teeth between the 2 treatment groups will be performed using an online block randomization technique (block of 6) with the tooth as unit of randomization. Time taken for each procedure will be recorded by the research assistant each visit prospectively after achieving local anaesthesia till the end of procedure. Patients will be asked to rate their satisfaction with the received treatment on the end of treatment visit using a designed questionnaire. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
- Conditions
- Molar Incisor Hypomineralisation, Dental Caries
- Being tested
- Selective caries removal, Non-Selective caries removal
- Keywords
- Molar Incisor Hypomineralisation, Selective caries removal, Non-selective caries removal
- Medical subject headings
- Molar Hypomineralization, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective caries removalProcedure or surgery
Selective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration.
Non-Selective caries removalProcedure or surgery
Complete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| Selective caries removal | Experimental | Selective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration. Receives: Procedure: Selective caries removal |
| Non-Selective caries removal | Experimental | Complete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment. Receives: Procedure: Non-Selective caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Radiographic Success
No radiographic evidence of periapical changes indicative of apical periodontitis
Measured: 6,12 months
Rate of Clinical Success
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
Measured: 6,12 months
Secondary outcomes (3)
Patient acceptance of treatment
Self-reported child acceptance using questionnaire
Measured: immediately following intervention, and at 6 and 12 months recall
Time taken for intervention
Time taken to perform intervention in minutes.
Measured: Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.
Child pain score
Self-reported Child pain score preoperatively and one week after intervention, recorded on a scale of 0-10.
Measured: preoperatively and one week following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142629
- Sponsor's protocol ID
- 413 - 2024
- Other IDs
- 20240457 .
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Versus Non-selective Caries Excavation in MIH Affected Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07142629
- Acronym / sponsor ID
- 413 - 2024
- Conditions
- Molar Incisor Hypomineralisation, Dental Caries
- Keywords
- Molar Incisor Hypomineralisation, Selective caries removal, Non-selective caries removal
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Aug 2025 (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 of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.
Detailed description
The aim of this study is to compare the clinical and radiographic outcomes of selective versus nonselective caries removal in MIH affected teeth with deep carious lesions using enhanced clinical protocols.Cases will be collected from the undergraduate and postgraduate clinics over a 6 months\' period according to predetermined inclusion criteria. Preoperative clinical and radiographic assessment will be conducted to MIH affected molars. MIH molars with deep caries (assymptomatic/ with symptoms of reversible pulpitis) will be randomly allocated for the choice of treatment with selective or non -selective caries excavation. Randomization of teeth between the 2 treatment groups will be performed using an online block randomization technique (block of 6) with the tooth as unit of randomization. Time taken for each procedure will be recorded by the research assistant each visit prospectively after achieving local anaesthesia till the end of procedure. Patients will be asked to rate their satisfaction with the received treatment on the end of treatment visit using a designed questionnaire. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective caries removal | Experimental | Procedure: Selective caries removalSelective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration. |
| Non-Selective caries removal | Experimental | Procedure: Non-Selective caries removalComplete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The patient age \<13 years old
- Non -contributory medical history
- Molar affected with MIH as per EAPD diagnostic criteria (White, creamy, or yellow to brownish opacities greater than one millimeter with/without postoperative enamel breakdown).
- Deep caries extending\>= 2/3 of dentine but not exposing the pulp on the bitewing radiograph.
- The tooth should give positive response to cold sensibility testing.
Key exclusion criteria (6 listed)
- Medically compromised patient.
- Non-restorable tooth.
- Clinical diagnosis of irreversible pulpitis.
- Signs of pulpal necrosis including sinus tract or swelling.
- Teeth indicated for extraction for orthodontic reasons.
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 |
|---|---|---|
| Selective caries removalSelective carious removal to firm dentine. Subsequently, 2 mm of Biodentine will be placed as a liner over the pulpal wall leaving the peripheries of the cavity available for bonding of the subsequent restoration. | Procedure or surgery | Selective caries removal |
| Non-Selective caries removalComplete caries excavation will be done to hard scratchy dentine, with the aid of caries detector dye.If no pulp exposure is evident 2 mm of Biodentine will be placed and the cavity will be restored. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be attempted with Biodentine as a capping material. If no hemostasis is achieved, then the procedure will be modified to either partial pulpotomy, full pulpotomy or RCT depending on the clinical assessment. | Procedure or surgery | Non-Selective caries removal |
Primary outcome
Rate of Radiographic Success
Time frame: 6,12 months
No radiographic evidence of periapical changes indicative of apical periodontitis
Rate of Clinical Success
Time frame: 6,12 months
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
3 secondary outcomes
Patient acceptance of treatment
Time frame: immediately following intervention, and at 6 and 12 months recall
Time taken for intervention
Time frame: Perioperative/Periprocedural: from the time the child sits on the dental chair and until the intervention is completed.
Child pain score
Time frame: preoperatively and one week following the intervention
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 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective caries removal and Non-Selective caries removal in people with Molar Incisor Hypomineralisation and Dental Caries, run by King Abdullah University Hospital at 1 site in Jordan.
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 9 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of Radiographic Success (time frame: 6,12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2025.