Molar-Incisor Hypomineralization (MIH)NCT07718191
Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars
A study testing 3d printed restoration and composite in people with Molar-Incisor Hypomineralization (MIH), run by Cairo University.
Trial summary
The aim of this clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- 3d printed restoration and composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Dec 2027
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants aged from 7 years to 11 years
- MIH-TNI 2 or 4
- No past dental treatment for the hypomineralized first permanent mandibular molars.
- Caries lesions that include the occlusal surface.
Who cannot join
- The presence of systemic disease, physical or mental disability.
- Any potential confounding enamel defects i.e., amelogenesis imperfecta.
- Uncooperative children.
- A history of allergic reactions to local anesthetics or some components of restorative materials
- History of spontaneous pain.
- Presence of clinical or radiographic signs of pulp necrosis (Fistula/abscess, internal or external root resorption, mobility of the tooth, and swelling).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars: A Randomized Clinical Trial
The aim of this clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- 3d printed restoration, composite
- Keywords
- MIH
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed restorationOther
3d hybrid resin restoration
compositeOther
direct resin composite
| Study group | Role | What they receive |
|---|---|---|
| 3d printed restoration | Experimental | Not described Receives: Other: 3d printed restoration |
| direct composite restoration | Active comparator | Not described Receives: Other: composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of self-reported pain
Self-reported pain was assessed considering each MIH affected FPM included in the study, using the faces pain scale-revised (FPS-R) before and after the restoration. This scale is made up of six faces, each representing an increase in the degree of pain fromleft to right. The scores of the faces are 0, 2, 4, 6, 8, and 10
Measured: 12 months
Secondary outcomes (1)
percentage of clinical survival of restoration
Restorations were clinically evaluated according to the restoration quality analysis criteria proposed by the United States Public Health Services USPHS-Modified for periods of 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Elhabbak, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718191
- Sponsor's protocol ID
- PhD-2026
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07718191
- Acronym / sponsor ID
- PhD-2026
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- MIH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2026 (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 clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3d printed restoration | Experimental | Other: 3d printed restoration |
| direct composite restoration | Active comparator | Other: composite |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants aged from 7 years to 11 years
- MIH-TNI 2 or 4
- No past dental treatment for the hypomineralized first permanent mandibular molars.
- Caries lesions that include the occlusal surface.
Key exclusion criteria (6 listed)
- The presence of systemic disease, physical or mental disability.
- Any potential confounding enamel defects i.e., amelogenesis imperfecta.
- Uncooperative children.
- A history of allergic reactions to local anesthetics or some components of restorative materials
- History of spontaneous pain.
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 |
|---|---|---|
| 3d printed restoration3d hybrid resin restoration | Other | 3d printed restoration |
| compositedirect resin composite | Other | direct composite restoration |
Primary outcome
evaluation of self-reported pain
Time frame: 12 months
Self-reported pain was assessed considering each MIH affected FPM included in the study, using the faces pain scale-revised (FPS-R) before and after the restoration. This scale is made up of six faces, each representing an increase in the degree of pain fromleft to right. The scores of the faces are 0, 2, 4, 6, 8, and 10
1 secondary outcome
percentage of clinical survival of restoration
Time frame: 12 months
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 21 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed restoration and composite in people with Molar-Incisor Hypomineralization (MIH), run by Cairo 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 4 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: opening soon, as of the sponsor's last update on 21 Jul 2026. 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?
Contact elhabbak (+201005889936, mahahabbak6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of self-reported pain (time frame: 12 months). 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 21 Jul 2026.