Molar Incisor HypomineralizationNCT05434884
Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH
A study testing occlusal veneer restorations and endocrown restorations in people with Molar Incisor Hypomineralization, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic)… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- occlusal veneer restorations and endocrown restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2020to 1 Mar 2022
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient from 8 to 13 years
- permanent first molar tooth affected with different severity levels of MIH
- Ability to physically and psychologically tolerate conventional restorative procedures.
Who cannot join
- Patients have active periodontal diseases.
- Patient with poor oral hygiene and motivation.
- Patient with psychiatric problems or unrealistic expectations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Two CAD/CAM Fabricated Ceramic Restorations With Different Preparation Designs for Rehabilitation Of Permanent First Molars Affected With Molar Incisor Hypomineralisation (MIH): Clinical Randomized Trial
This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (MIH), evaluated at different time periods
Read the detailed description
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- occlusal veneer restorations, endocrown restorations
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal veneer restorationsProcedure or surgery
occlusal veneer preparation with circumferential chamfer finish line and proximal slot " proposed modified occlusal veneer design" for rehabilitation of moderate level of permanent first molars. OrPatients will receive endocrown restorations for rehabilitation of sever level of permanent first molars
endocrown restorationsProcedure or surgery
endocrown restorations
| Study group | Role | What they receive |
|---|---|---|
| OV group | Experimental | Patients will receive occlusal veneer restorations Receives: Procedure: occlusal veneer restorations |
| EN group | Experimental | Patients will receive endocrown restorations Receives: Procedure: endocrown restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation
Measured: 1 year
marginal integrity
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria, at 6 months after cementation
Measured: 6 months
colour stability
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria, at 12 months after cementation
Measured: 12 months
Elimination of sensitivity
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria, at 3, months after cementation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start10 Jul 2020
- Primary completion10 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Altura
- Responsible party
- Principal investigator, sara nabil, Al-Azhar University
- Investigators
- Mona Hossam, professor, Study director, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434884
- Sponsor's protocol ID
- AlAzharUniversity
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: sharing primary results only
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two CAD/CAM Fabricated Ceramic Restorations With Different Preparation Designs for Rehabilitation Of Permanent First Molars Affected With Molar Incisor Hypomineralisation (MIH): Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT05434884
- Acronym / sponsor ID
- AlAzharUniversity
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Altura
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 Jun 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.
This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (MIH), evaluated at different time periods
Detailed description
Clinical evaluation of all restorations will be performed according to:
- Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| OV group | Experimental | Procedure: occlusal veneer restorationsPatients will receive occlusal veneer restorations |
| EN group | Experimental | Procedure: endocrown restorationsPatients will receive endocrown restorations |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient from 8 to 13 years
- permanent first molar tooth affected with different severity levels of MIH
- Ability to physically and psychologically tolerate conventional restorative procedures.
Key exclusion criteria (3 listed)
- Patients have active periodontal diseases.
- Patient with poor oral hygiene and motivation.
- Patient with psychiatric problems or unrealistic expectations
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 |
|---|---|---|
| occlusal veneer restorationsocclusal veneer preparation with circumferential chamfer finish line and proximal slot " proposed modified occlusal veneer design" for rehabilitation of moderate level of permanent first molars. OrPatients will receive endocrown restorations for rehabilitation of sever level of permanent first molars | Procedure or surgery | OV group |
| endocrown restorationsendocrown restorations | Procedure or surgery | EN group |
Primary outcome
retention
Time frame: 1 year
Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria,at12 month after cementation
marginal integrity
Time frame: 6 months
Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 6 months after cementation
colour stability
Time frame: 12 months
Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 12 months after cementation
Elimination of sensitivity
Time frame: 3 months
Clinical evaluation of all restorations will be performed according to: - Modified United States Public Health Service (USPHS) Ryge Criteria, at 3, months after cementation
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 28 Jun 2022.
- Individual participant dataSharing planned: No. sharing primary results only
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Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
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Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
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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.
Mona Hossam, professor study director
doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal veneer restorations and endocrown restorations in people with Molar Incisor Hypomineralization, run by Al-Azhar University 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 3 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 28 Jun 2022. 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?
retention (time frame: 1 year). The study lists 4 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 28 Jun 2022.