Molar Incisor HypomineralizationNCT05494749
Zirconia Reinforced Glass Ionomer in MIH
A study testing zirconomer and HVGI-Equia Forte in people with Molar Incisor Hypomineralization, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- zirconomer and HVGI-Equia Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children free from any systemic disease (ASA I).
- Cooperative children showing positive or definitely positive behavior according to Frankl rating scale
- Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b)
- Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6
- No clinical or radiographic evidence of pulpal involvement.
Who cannot join
- Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index.
- Patients whose parents will not give their consent to participate in the study
- Non-restorable first permanent molars indicated for extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)
Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- zirconomer, HVGI-Equia Forte
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconomerOther
teeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations
HVGI-Equia ForteOther
teeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: zirconomer |
| Control | Active comparator | Not described Receives: Other: HVGI-Equia Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical success rate
It will be assessed using Modified ART criteria, restorations receiving a score of:
(0) Restoration is present and satisfactory OR
(1) Restoration is present, slight defect at the cavity margin of less than 0.5 mm; no repair is needed.
will be considered successful, and any other score will be considered a failure.
Measured: at 3 months, 6 months, 9 months, 12 months
Secondary outcomes (3)
Change in pain
Pain will be recorded using VAS Using a visual analog scale (VAS), the subjects were instructed how to point to the position of the line between faces to indicate how much painthey might feel. In this system, the total scores range from 0 to 100 based on measuring the distance in millimeters from the left end bar to the mark made by the child on the 10 cm line anchored by happy to sad faces, with a higher score indicating more severe pain.
Measured: at 1 week, 3 months, 6 months, 9 months, 12 months
Change in sensitivity
sensitivity will be recorded using VAS by performing air blast test Using a visual analog scale (VAS), the subjects were instructed how to point to the position of the line between faces to indicate how much pain they might feel. In this system, the total scores range from 0 to 100 based on measuring the distance in millimeters from the left end bar to the mark made by the child on the 10 cm line anchored by happy to sad faces, with a higher score indicating more severe pain.
Measured: at 1 week, 3 months, 6 months, 9 months, 12 months
Finite element analysis
Performance of both Zirconomer and HVGI-Equia Forte under dynamic occlusal loads will be assessed using Finite Element Analysis using ANSYS software.
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 posted10 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 Molar Incisor HypomineralizationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Reham A Mahfouz, MSc, Principal investigator, Alexandria University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494749
- Sponsor's protocol ID
- MIH_2022
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahfouz RA, Hanno AG, Rahman AMAE. Zirconia-reinforced glass ionomer restorations in molar incisor hypomineralization: a randomized controlled clinical trial. Clin Oral Investig. 2025 May 8;29(6):290. doi: 10.1007/s00784-025-06352-y.
PubMed 40335753
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)
- ClinicalTrials.gov ID
- NCT05494749
- Acronym / sponsor ID
- MIH_2022
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Aug 2022 (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.
Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: zirconomer |
| Control | Active comparator | Other: HVGI-Equia Forte |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children free from any systemic disease (ASA I).
- Cooperative children showing positive or definitely positive behavior according to Frankl rating scale
- Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b)
- Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6
- No clinical or radiographic evidence of pulpal involvement.
Key exclusion criteria (3 listed)
- Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index.
- Patients whose parents will not give their consent to participate in the study
- Non-restorable first permanent molars indicated for extraction
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 |
|---|---|---|
| zirconomerteeth meeting the inclusion criteria are assigned to receive Zirconomer® restorations | Other | Test group |
| HVGI-Equia Forteteeth meeting the inclusion criteria are assigned to receive HVGI-Equia Forte® restorations. | Other | Control |
Primary outcome
Change in clinical success rate
Time frame: at 3 months, 6 months, 9 months, 12 months
It will be assessed using Modified ART criteria, restorations receiving a score of: (0) Restoration is present and satisfactory OR (1) Restoration is present, slight defect at the cavity margin of less than 0.5 mm; no repair is needed. will be considered successful, and any other score will be considered a failure.
3 secondary outcomes
Change in pain
Time frame: at 1 week, 3 months, 6 months, 9 months, 12 months
Change in sensitivity
Time frame: at 1 week, 3 months, 6 months, 9 months, 12 months
Finite element analysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 40335753Mahfouz RA, Hanno AG, Rahman AMAE. Zirconia-reinforced glass ionomer restorations in molar incisor hypomineralization: a randomized controlled clinical trial. Clin Oral Investig. 2025 May 8;29(6):290. doi: 10.1007/s00784-025-06352-y.
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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.
Reham A Mahfouz, MSc principal investigator
Alexandria University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zirconomer and HVGI-Equia Forte in people with Molar Incisor Hypomineralization, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in clinical success rate (time frame: at 3 months, 6 months, 9 months, 12 months). 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 NCT05494749, 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 19 Mar 2024.