Molar Incisor HypomineralizationNCT05529329
Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH
A study testing overlay in people with Molar Incisor Hypomineralization, run by Al-Azhar University at 1 site in Egypt.
Trial summary
the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- overlay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 20 Aug 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children's age ranging from 10 to 15 years old.
- Existence of large carious lesion in young permanent first molar teeth associated with weak cusps.
- Signs of vital pulp without symptoms of pulpitis.
- Presence of antagonists and adjacent teeth and occlusal contacts with good level of oral hygiene.
- Children should be able to physically and psychologically tolerate conventional restorative procedures.
Who cannot join
- Children with poor oral hygiene and symptoms of pulpitis.
- Children suffer from parafunctional habits.
- Children with any debilitating systemic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Zirconia Versus Lithium Di-silicate Overlays Restorations for Restoring Vital Young Permanent First Molar Teeth Affected With Moderate Form of Molar Incisor Hypomineralization: Randomized Clinical Trial
the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial.
Read the detailed description
To compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restorations. Materials and methods: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- overlay
- Keywords
- MIH - zironia - Lithium Disilicate - Overlays
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overlayProcedure or surgery
Also called Zirconia partial coverage of hypo-mineralized defected enamel
Lithium Disilicate partial coverage of hypo-mineralized defected enamel
| Study group | Role | What they receive |
|---|---|---|
| Group (Z) | Active comparator | patients received zirconia restorations group Receives: Procedure: overlay |
| Group (EC) | Experimental | patients received IPS E.max Cad restorations group Receives: Procedure: overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
compare the one-year clinical outcome of zirconia versus lithium disilicate overlays
restoration of vital young permanent first molar teeth affected with moderate form of Molar Incisor Hypomineralization
Measured: one year
Restoration Evaluation
Restorations were assessed clinically using dental explorer, mirror and radiographically according to FDI World Dental Federation criteria over one-year period at (base line "1 week", 3, 6 and 12 months) afterward cementation. There were three assessment categories (esthetics, function, biological) each with five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. Statistical analysis for baseline and follow-up criteria was performed with Wilcoxon-Test (p<0.05) (SPSS; IBM,Chicago, IL).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion20 Aug 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 Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMMohammed, Al-Azhar University
- Investigators
- alaa F mohammed, Ph. D, Principal investigator, Al-Azhar University- faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529329
- Sponsor's protocol ID
- REC-PD-21-08
- Status last verified
- Feb 2023
- First submitted
- 2 Sep 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Zirconia Versus Lithium Di-silicate Overlays Restorations for Restoring Vital Young Permanent First Molar Teeth Affected With Moderate Form of Molar Incisor Hypomineralization: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05529329
- Acronym / sponsor ID
- REC-PD-21-08
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- MIH - zironia - Lithium Disilicate - Overlays
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 7 Sep 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.
the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial.
Detailed description
To compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restorations. Materials and methods: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group (Z) | Active comparator | Procedure: overlaypatients received zirconia restorations group |
| Group (EC) | Experimental | Procedure: overlaypatients received IPS E.max Cad restorations group |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children's age ranging from 10 to 15 years old.
- Existence of large carious lesion in young permanent first molar teeth associated with weak cusps.
- Signs of vital pulp without symptoms of pulpitis.
- Presence of antagonists and adjacent teeth and occlusal contacts with good level of oral hygiene.
- Children should be able to physically and psychologically tolerate conventional restorative procedures.
Key exclusion criteria (3 listed)
- Children with poor oral hygiene and symptoms of pulpitis.
- Children suffer from parafunctional habits.
- Children with any debilitating systemic disorder.
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 |
|---|---|---|
| overlayAlso: Zirconia partial coverage of hypo-mineralized defected enamelLithium Disilicate partial coverage of hypo-mineralized defected enamel | Procedure or surgery | Group (EC), Group (Z) |
Primary outcome
Clinical Outcome
Time frame: one year
compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restoration of vital young permanent first molar teeth affected with moderate form of Molar Incisor Hypomineralization
Restoration Evaluation
Time frame: one year
Restorations were assessed clinically using dental explorer, mirror and radiographically according to FDI World Dental Federation criteria over one-year period at (base line "1 week", 3, 6 and 12 months) afterward cementation. There were three assessment categories (esthetics, function, biological) each with five subcategories. From best to worst, the subcategories were: (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure. Statistical analysis for baseline and follow-up criteria was performed with Wilcoxon-Test (p<0.05) (SPSS; IBM,Chicago, IL).
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 3 Feb 2023.
- Individual participant dataSharing planned: Yes. Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria
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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.
alaa F mohammed, Ph. D principal investigator
Al-Azhar 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 overlay 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 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 3 Feb 2023. 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?
Clinical Outcome (time frame: one year). 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 3 Feb 2023.