Molar Hypomineralization, IncisorNCT07144605
Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study
A study testing CAD-CAM, indirect restorations in people with Molar Hypomineralization, Incisor, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study is about the long-term survival success of different, externally prepared fillings (Indirect restoration, CAD-CAM blocks) used in teeth with reduced mineral structure, namely Molar Incisor Hypomineralization (MIH), which is called chalk teeth in children. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Hypomineralization, Incisor
- What is being tested?
- CAD-CAM, indirect restorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 20 Jul 2025
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically healthy
- Cooperative (Frankl 3-4)
- Diagnosed with MIH for at least one permanent tooth
- Symmetrical mandibular molars that fit the middle MIH classification (teeth with a tooth score of 7-9 in MIHSI)
- Teeth without indication for root canal treatment
- Teeth without percussion, abscess and fistula formation
Show all 16Show fewer
- Without periapical lesions
- With post-eruption enamel fractures in the relevant teeth
- Without mobility and pathological gingival pockets
- Patients who agreed to participate in the study.
- Exclusion Criteria:Teeth that are suitable for mild and severe classification
- Non-cooperative (Frankl 1 and Frankl 2)
- Teeth with extraction indication
- Teeth that require root canal treatment
- Teeth with periapical lesions, abscesses and fistula formation
- Patients with mobility and pathological gingival pockets
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
This study is about the long-term survival success of different, externally prepared fillings (Indirect restoration, CAD-CAM blocks) used in teeth with reduced mineral structure, namely Molar Incisor Hypomineralization (MIH), which is called chalk teeth in children.
Read the detailed description
The aim of this study was to comparatively evaluate the long-term survival times and clinical success of nano-ceramic hybrid CAD-CAM blocks, Grandio Blocs (R) (VOCO), and glass-ceramic blocks, GC INITIAL LiSi (GC AMERICA INC. USA), according to USPHS criteria, after pulpal treatment in mandibular teeth with bilateral moderate molar incisor hypomineralization.
- Conditions
- Molar Hypomineralization, Incisor
- Being tested
- CAD-CAM, indirect restorations
- Keywords
- CAD-CAM, Indirect restorations, Molar Incisor Hypomineralization, 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.
CAD-CAM, indirect restorationsOther
Indirect restorations that we think will last longer than traditional filling materials in teeth with molar hypomineralization.
| Study group | Role | What they receive |
|---|---|---|
| Voco Grandio blocs(Grandio Blocs (R) VOCO) | Experimental | Nanohybrid ceramic blocks, indirect restorative materials Receives: Other: CAD-CAM, indirect restorations |
| GC INITIAL LiSi Blocs (GC AMERICA INC. USA) | Experimental | Glass ceramic blocks, indirect restorative materials Receives: Other: CAD-CAM, indirect restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
the clinical status of the restorations
The restorations were clinically evaluated in the oral cavity using the USPHS index.
Measured: up to 6 months after intervention
the status of the periapical tissues
The periapical tissue status was assessed according to the Periapical Index (PAI).
Measured: Up to the 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Jun 2024
- Primary completion20 Jul 2024
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Hypomineralization, IncisorStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- In our study, treatment was planned for moderately affected teeth according to the MIH Severity Index. The study was designed as a prospective, randomized, split-mouth trial. Group randomization was performed using the sealed envelope technique. In the same patient, VOCO GrandioBloc (VOCO GmbH, Cuxhaven, Germany) was applied to one tooth, while a GC Initial lithium disilicate block was applied to the symmetrical contralateral tooth.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Altan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144605
- Sponsor's protocol ID
- NecmettinEU05
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants don't want to share the individual information about study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study
- ClinicalTrials.gov ID
- NCT07144605
- Acronym / sponsor ID
- NecmettinEU05
- Conditions
- Molar Hypomineralization, Incisor
- Keywords
- CAD-CAM, Indirect restorations, Molar Incisor Hypomineralization, MIH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 27 Aug 2025 (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 is about the long-term survival success of different, externally prepared fillings (Indirect restoration, CAD-CAM blocks) used in teeth with reduced mineral structure, namely Molar Incisor Hypomineralization (MIH), which is called chalk teeth in children.
Detailed description
The aim of this study was to comparatively evaluate the long-term survival times and clinical success of nano-ceramic hybrid CAD-CAM blocks, Grandio Blocs (R) (VOCO), and glass-ceramic blocks, GC INITIAL LiSi (GC AMERICA INC. USA), according to USPHS criteria, after pulpal treatment in mandibular teeth with bilateral moderate molar incisor hypomineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In our study, treatment was planned for moderately affected teeth according to the MIH Severity Index. The study was designed as a prospective, randomized, split-mouth trial. Group randomization was performed using the sealed envelope technique. In the same patient, VOCO GrandioBloc (VOCO GmbH, Cuxhaven, Germany) was applied to one tooth, while a GC Initial lithium disilicate block was applied to the symmetrical contralateral tooth.
| Arm | Type | Receives |
|---|---|---|
| Voco Grandio blocs(Grandio Blocs (R) VOCO) | Experimental | Other: CAD-CAM, indirect restorationsNanohybrid ceramic blocks, indirect restorative materials |
| GC INITIAL LiSi Blocs (GC AMERICA INC. USA) | Experimental | Other: CAD-CAM, indirect restorationsGlass ceramic blocks, indirect restorative materials |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Systemically healthy
- Cooperative (Frankl 3-4)
- Diagnosed with MIH for at least one permanent tooth
- Symmetrical mandibular molars that fit the middle MIH classification (teeth with a tooth score of 7-9 in MIHSI)
- Teeth without indication for root canal treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CAD-CAM, indirect restorationsIndirect restorations that we think will last longer than traditional filling materials in teeth with molar hypomineralization. | Other | GC INITIAL LiSi Blocs (GC AMERICA INC. USA), Voco Grandio blocs(Grandio Blocs (R) VOCO) |
Primary outcome
the clinical status of the restorations
Time frame: up to 6 months after intervention
The restorations were clinically evaluated in the oral cavity using the USPHS index.
the status of the periapical tissues
Time frame: Up to the 6th months
The periapical tissue status was assessed according to the Periapical Index (PAI).
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 27 Aug 2025.
- https://link.springer.com/article/10.1007/s10266-023-00841-wLink provided by the sponsor.
- Individual participant dataSharing planned: No. The participants don't want to share the individual information about study.
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Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
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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 CAD-CAM, indirect restorations in people with Molar Hypomineralization, Incisor, run by Necmettin Erbakan 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 16 inclusion and 0 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 27 Aug 2025. 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?
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?
the clinical status of the restorations (time frame: up to 6 months after intervention). 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 27 Aug 2025.