Molar HypomineralizationNCT06456619
CAD-CAM or Adhesive Approaches for MIH Treatment
A study testing Tooth restoration in people with Molar Hypomineralization and Dental Restoration Failure of Marginal Integrity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Hypomineralization, Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Tooth restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 15 Feb 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with first and second permanent molar teeth that have loss of more than one surface due to hypomineralization and seen with white, brown, or yellow opacities on anterior permanent teeth
- Patients without any systemic, physical, physiological, or allergic conditions
Who cannot join
- Patients who had symptoms during the follow-up periods
- Patients who did not attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization
Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization.
The main questions aim to answer are:
Read more
- The clinical success rate of CAD-CAM supported restorations
- The highest clinical success rate for restoring hypomineralized teeth.
Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p<0.05.
Read the detailed description
After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.
- Being tested
- Tooth restoration
- Keywords
- Molar incisor hypomineralization, CAD-CAM supported restoration, Composite resin 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.
Tooth restorationOther
Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children
| Study group | Role | What they receive |
|---|---|---|
| Composite resin (Filtek Z250, 3M ESPE) | Active comparator | A pretreatment protocol including sodium hypochlorite and ortho-phosphoric acid was applied to the tooth surface. Then, the tooth was restored with a composite resin material (Filtek Z250, 3M ESPE). This protocol is a clinically approved way for restoring hypomineralized teeth. Receives: Other: Tooth restoration |
| CAD-CAM supported (Cerasmart, GC Dental) | Experimental | The preparation was completed by making bevels on the enamel surfaces. Then, an intraoral impression was taken to sent to the laboratory for manufacturing CAD-CAM-supported restoration with a nanohybrid ceramic material (Cerasmart, GC Dental). CAD-CAM supported restorations can be done by using a lot of restorative blocks by milling them. In this study, we preferred using resin-based blocks (Cerasmart, GC Dental) to compare with the control group. Receives: Other: Tooth restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation (Modified USPHS criteria- Anatomic form)
Anatomic form was examined by inspection at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Surface roughness)
Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Marginal adaptation)
Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Marginal discoloration)
Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Retention)
Retention was examined by inspection and probing at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Color stability)
Color stability was examined by inspection at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Secondary caries)
Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.
Measured: 24 months
Clinical evaluation (Modified USPHS criteria-Proximal contact)
Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.
Measured: 24 months
Radiographical evaluation (Lamina dura)
Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Measured: 24 months
Radiographical evaluation (Change in inter-root trabeculation continuity)
Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Measured: 24 months
Radiographical evaluation (Radiolucent area development)
Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jan 2020
- Primary completion15 Sep 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar 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
- Model description
- Observational clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didem Sakaryalı Uyar, PhD MD, DDS, Principal investigator, Başkent Universiry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456619
- Sponsor's protocol ID
- D-KA19/04
- Status last verified
- Jun 2024
- First submitted
- 6 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about patients might be requested from the principal author due to reasonable cause.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT06456619
- Acronym / sponsor ID
- D-KA19/04
- Keywords
- Molar incisor hypomineralization, CAD-CAM supported restoration, Composite resin restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 13 Jun 2024 (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.
Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization.
The main questions aim to answer are:
- The clinical success rate of CAD-CAM supported restorations
- The highest clinical success rate for restoring hypomineralized teeth.
Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p<0.05.
Detailed description
After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Observational clinical trial
| Arm | Type | Receives |
|---|---|---|
| Composite resin (Filtek Z250, 3M ESPE) | Active comparator | Other: Tooth restorationA pretreatment protocol including sodium hypochlorite and ortho-phosphoric acid was applied to the tooth surface. Then, the tooth was restored with a composite resin material (Filtek Z250, 3M ESPE). This protocol is a clinically approved way for restoring hypomineralized teeth. |
| CAD-CAM supported (Cerasmart, GC Dental) | Experimental | Other: Tooth restorationThe preparation was completed by making bevels on the enamel surfaces. Then, an intraoral impression was taken to sent to the laboratory for manufacturing CAD-CAM-supported restoration with a nanohybrid ceramic material (Cerasmart, GC Dental). CAD-CAM supported restorations can be done by using a lot of restorative blocks by milling them. In this study, we preferred using resin-based blocks (Cerasmart, GC Dental) to compare with the control group. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with first and second permanent molar teeth that have loss of more than one surface due to hypomineralization and seen with white, brown, or yellow opacities on anterior permanent teeth
- Patients without any systemic, physical, physiological, or allergic conditions
Key exclusion criteria (2 listed)
- Patients who had symptoms during the follow-up periods
- Patients who did not attend follow-up appointments
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 |
|---|---|---|
| Tooth restorationComparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children | Other | CAD-CAM supported (Cerasmart, GC Dental), Composite resin (Filtek Z250, 3M ESPE) |
Primary outcome
Clinical evaluation (Modified USPHS criteria- Anatomic form)
Time frame: 24 months
Anatomic form was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Surface roughness)
Time frame: 24 months
Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal adaptation)
Time frame: 24 months
Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal discoloration)
Time frame: 24 months
Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Retention)
Time frame: 24 months
Retention was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Color stability)
Time frame: 24 months
Color stability was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Secondary caries)
Time frame: 24 months
Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Proximal contact)
Time frame: 24 months
Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Lamina dura)
Time frame: 24 months
Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Change in inter-root trabeculation continuity)
Time frame: 24 months
Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Radiolucent area development)
Time frame: 24 months
Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-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 13 Jun 2024.
- Individual participant dataSharing planned: No. Information about patients might be requested from the principal author due to reasonable cause.
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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.
Didem Sakaryalı Uyar, PhD MD, DDS principal investigator
Başkent Universiry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth restoration in people with Molar Hypomineralization and Dental Restoration Failure of Marginal Integrity, run by Baskent 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 2 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: finished, as of the sponsor's last update on 13 Jun 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 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?
Clinical evaluation (Modified USPHS criteria- Anatomic form) (time frame: 24 months). The study lists 11 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 13 Jun 2024.