Molar Incisor HypomineralizationNCT05842590
Clinical Evaluation of Direct Composite Veneer Restorations
A study testing Composite Veneer Restoration in people with Molar Incisor Hypomineralization, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Composite Veneer Restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2022to Aug 2024
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
- Maxillary anterior teeth with MIH-caused coloring and opacity areas
- Fully erupted anterior teeth
Who cannot join
- Patients and parents of patients who accept to participate.
- Patients who are not in cooperation with the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Direct Composite Veneer Restorations Performed in Permanent Incisors Affected by Molar-Incisor Hypomineralization
The objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Composite Veneer Restoration
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite Veneer RestorationOther
This is a single-arm study. Direct composite veneer Restorations will be performed to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Direct Composite Veneer | Experimental | This is a single-arm study. Direct composite veneer restoration will be performed to all patients. Receives: Other: Composite Veneer Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Change from baseline to 12 months regarding "Anatomic form"
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Measured: baseline, 3-month, 6-month,12-month
2.Change from baseline to 12 months regarding "Marginal adaptation"
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
Measured: baseline, 3-month, 6-month,12-month
3.Change from baseline to 12 months regarding "Surface roughness"
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Measured: baseline, 3-month, 6-month,12-month
4.Change from baseline to 12 months regarding "Marginal staining"
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
Measured: baseline, 3-month, 6-month,12-month
5.Change from baseline to 12 months regarding "Retention"
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Measured: baseline, 3-month, 6-month,12-month
6.Change from baseline to 12 months regarding "Incisal wear"
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Measured: baseline, 3-month, 6-month,12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start2 Aug 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
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 Hacettepe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beste Ozgur, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842590
- Sponsor's protocol ID
- HUDHF-Veneer
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Direct Composite Veneer Restorations Performed in Permanent Incisors Affected by Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT05842590
- Acronym / sponsor ID
- HUDHF-Veneer
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 May 2023 (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 objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct Composite Veneer | Experimental | Other: Composite Veneer RestorationThis is a single-arm study. Direct composite veneer restoration will be performed to all patients. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
- Maxillary anterior teeth with MIH-caused coloring and opacity areas
- Fully erupted anterior teeth
Key exclusion criteria (2 listed)
- Patients and parents of patients who accept to participate.
- Patients who are not in cooperation with the procedure.
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 |
|---|---|---|
| Composite Veneer RestorationThis is a single-arm study. Direct composite veneer Restorations will be performed to all patients. | Other | Direct Composite Veneer |
Primary outcome
1.Change from baseline to 12 months regarding "Anatomic form"
Time frame: baseline, 3-month, 6-month,12-month
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
2.Change from baseline to 12 months regarding "Marginal adaptation"
Time frame: baseline, 3-month, 6-month,12-month
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
3.Change from baseline to 12 months regarding "Surface roughness"
Time frame: baseline, 3-month, 6-month,12-month
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
4.Change from baseline to 12 months regarding "Marginal staining"
Time frame: baseline, 3-month, 6-month,12-month
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
5.Change from baseline to 12 months regarding "Retention"
Time frame: baseline, 3-month, 6-month,12-month
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
6.Change from baseline to 12 months regarding "Incisal wear"
Time frame: baseline, 3-month, 6-month,12-month
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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. This study is not recruiting at the moment.
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 Composite Veneer Restoration in people with Molar Incisor Hypomineralization, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 6 May 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
1.Change from baseline to 12 months regarding "Anatomic form" (time frame: baseline, 3-month, 6-month,12-month). The study lists 6 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 6 May 2023.