Dental CariesNCT06222918
Investigation of the Effect of Deep Margin Elevation Technique on the Clinical Performance of Endocrown Restorations Produced by Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) System
A study testing Deep Margin Elevation (G-ænial Universal Injectable) in people with Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to investigate the impact of the deep margin elevation technique on the clinical performance of CAD/CAM endocrown restorations in deep Class II cavities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Deep Margin Elevation (G-ænial Universal Injectable)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2022to 25 Apr 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals without any uncontrolled systemic diseases.
- Individuals aged between 18 and 65 years.
- Individuals who pay attention to oral hygiene by brushing their teeth twice a day.
- Patients with at least one canal-treated posterior tooth, multiple cusp loss, and at least one tooth wall loss identified during intraoral examination.
- Patients who have successfully completed periodontal and endodontic treatments and do not exhibit any subjective symptoms.
- Voluntary individuals who agree to participate in the study and sign the informed consent form will be included in the research.
Who cannot join
- Individuals with uncontrolled systemic diseases.
- Individuals with mental retardation who cannot establish cooperation.
- Individuals with advanced periodontal disease.
- Individuals using removable partial dentures.
- Individuals with bruxism.
- Individuals with malocclusion.
- Patients with advanced substance loss requiring extraction of the relevant tooth, and individuals with deep margins requiring periodontal interventions.
- Individuals who, after being informed about the study, choose not to read the informed consent form and decline to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical study is to investigate the impact of the deep margin elevation technique on the clinical performance of CAD/CAM endocrown restorations in deep Class II cavities.
Read the detailed description
This study aims to evaluate the impact of the deep margin elevation technique on the clinical performance of endocrown restorations made from nano-ceramic blocks produced using the CAD/CAM system for class II cavities with deep margins. Factors such as color harmony with adjacent teeth and restorations, discoloration, anatomical form continuity, adaptation, secondary caries, and retention will be examined in the nano-ceramic block material.
Various treatment options are available for the restoration of posterior group teeth. Factors such as restoration material, condition of supporting tooth tissue, patient habits, and clinical protocols affect the lifespan of restorations. Advances in tooth preparations ensure the preservation of sound tooth structure and the longevity of restorations.
The CAD/CAM system is a technology used in dentistry, consisting of three essential elements: data acquisition, design, and production. With this system, dentists can design and produce restorations such as veneers, crowns, and bridges using digital modeling and manufacturing methods.
The restoration of endodontically treated teeth may require different approaches than post-core and crown restorations that can affect mechanical resistance. The development of adhesive techniques and the importance of minimally invasive dentistry have led to new therapeutic approaches, such as monolithic endocrown restorations fixed to the pulp chamber and cavity margins.
Dental adhesion is the attractive force between the tooth surface and the applied material, and dentin bonding systems have been developed to ensure adhesion between the two structures. These systems enhance adhesion by increasing dentin surface energy and facilitating the spread of adhesive resin into the dentin.
Procedures such as isolation, measurement, cementation, and residual cement cleaning can be challenging in cases with deep margins. Clinical strategies can assist in overcoming isolation difficulties in subgingival margin areas where adhesive procedures are applied.
The restoration of teeth with advanced substance loss can be a challenging process for operators, and the selection of the correct treatment plan is crucial. This clinical research aims to examine the impact of the deep marginal elevation technique on the clinical performance of CAD/CAM-produced endocrown restorations.
- Conditions
- Dental Caries
- Being tested
- Deep Margin Elevation (G-ænial Universal Injectable)
- Keywords
- CAD/CAM, Endocrown, Deep Margin Elevation, İndirect
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Margin Elevation (G-ænial Universal Injectable)Procedure or surgery
Deep margin elevation (DME), or coronal margin relocation (CMR), is a procedure used to raise or reposition sub-gingival margins into supra-gingival margins using several materials to increase marginal integrity and bonding strength
| Study group | Role | What they receive |
|---|---|---|
| Supragingival margins | No intervention | Not described |
| Subgingival margins (G-ænial Universal Injectable) | Active comparator | Matrix: Methacrylate monomer %31. Fillers: Silica, Barium Glass %69
G-ænial Universal injectable is a light-cured, radiopaque universal high-strength composite that can be used for all restorative indications while offering excellent viscosity and perfect direct syringe application. It has enhanced thixotropic properties that allow you to create the most beautiful \& durable restorations with a minimum of manipulation. Receives: Procedure: Deep Margin Elevation (G-ænial Universal Injectable) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorations materyal. Charlie: Any loss of restorative material
Measured: From baseline to 24 month
Marginal discoloration
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding Marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scorsese: Alfa: No discoloration. Bravo: Discoloration without. Charlie:Discoloration with penetration in pulpal direction
Measured: From baseline to 24 month
Marginal Adaptation
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Measured: From baseline to 24 month
Seconder Caries
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries presented. Charlie Caries present
Measured: From baseline to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start25 Dec 2022
- Primary completion25 Jun 2023
- Study completion25 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Adson, Hacettepe University
- Investigators
- Şükran Bolay, Prof., Principal investigator, Hacettepe UniversityTaha Yasin Sarıkaya, Principal investigator, Hacettepe UniversityOnur Adson, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222918
- Sponsor's protocol ID
- KA-22110
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.
PubMed 20305873Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.
PubMed 29153552
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Deep Margin Elevation Technique on the Clinical Performance of Endocrown Restorations Produced by Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) System
- ClinicalTrials.gov ID
- NCT06222918
- Acronym / sponsor ID
- KA-22110
- Conditions
- Dental Caries
- Keywords
- CAD/CAM, Endocrown, Deep Margin Elevation, İndirect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Apr 2024 (estimated)
- First posted
- 25 Jan 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.
The aim of this clinical study is to investigate the impact of the deep margin elevation technique on the clinical performance of CAD/CAM endocrown restorations in deep Class II cavities.
Detailed description
This study aims to evaluate the impact of the deep margin elevation technique on the clinical performance of endocrown restorations made from nano-ceramic blocks produced using the CAD/CAM system for class II cavities with deep margins. Factors such as color harmony with adjacent teeth and restorations, discoloration, anatomical form continuity, adaptation, secondary caries, and retention will be examined in the nano-ceramic block material.
Various treatment options are available for the restoration of posterior group teeth. Factors such as restoration material, condition of supporting tooth tissue, patient habits, and clinical protocols affect the lifespan of restorations. Advances in tooth preparations ensure the preservation of sound tooth structure and the longevity of restorations.
The CAD/CAM system is a technology used in dentistry, consisting of three essential elements: data acquisition, design, and production. With this system, dentists can design and produce restorations such as veneers, crowns, and bridges using digital modeling and manufacturing methods.
The restoration of endodontically treated teeth may require different approaches than post-core and crown restorations that can affect mechanical resistance. The development of adhesive techniques and the importance of minimally invasive dentistry have led to new therapeutic approaches, such as monolithic endocrown restorations fixed to the pulp chamber and cavity margins.
Dental adhesion is the attractive force between the tooth surface and the applied material, and dentin bonding systems have been developed to ensure adhesion between the two structures. These systems enhance adhesion by increasing dentin surface energy and facilitating the spread of adhesive resin into the dentin.
Procedures such as isolation, measurement, cementation, and residual cement cleaning can be challenging in cases with deep margins. Clinical strategies can assist in overcoming isolation difficulties in subgingival margin areas where adhesive procedures are applied.
The restoration of teeth with advanced substance loss can be a challenging process for operators, and the selection of the correct treatment plan is crucial. This clinical research aims to examine the impact of the deep marginal elevation technique on the clinical performance of CAD/CAM-produced endocrown restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supragingival margins | No intervention | – |
| Subgingival margins (G-ænial Universal Injectable) | Active comparator | Procedure: Deep Margin Elevation (G-ænial Universal Injectable)Matrix: Methacrylate monomer %31. Fillers: Silica, Barium Glass %69 G-ænial Universal injectable is a light-cured, radiopaque universal high-strength composite that can be used for all restorative indications while offering excellent viscosity and perfect direct syringe application. It has enhanced thixotropic properties that allow you to create the most beautiful \& durable restorations with a minimum of manipulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy individuals without any uncontrolled systemic diseases.
- Individuals aged between 18 and 65 years.
- Individuals who pay attention to oral hygiene by brushing their teeth twice a day.
- Patients with at least one canal-treated posterior tooth, multiple cusp loss, and at least one tooth wall loss identified during intraoral examination.
- Patients who have successfully completed periodontal and endodontic treatments and do not exhibit any subjective symptoms.
Key exclusion criteria (8 listed)
- Individuals with uncontrolled systemic diseases.
- Individuals with mental retardation who cannot establish cooperation.
- Individuals with advanced periodontal disease.
- Individuals using removable partial dentures.
- Individuals with bruxism.
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 |
|---|---|---|
| Deep Margin Elevation (G-ænial Universal Injectable)Deep margin elevation (DME), or coronal margin relocation (CMR), is a procedure used to raise or reposition sub-gingival margins into supra-gingival margins using several materials to increase marginal integrity and bonding strength | Procedure or surgery | Subgingival margins (G-ænial Universal Injectable) |
Primary outcome
Retention
Time frame: From baseline to 24 month
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorations materyal. Charlie: Any loss of restorative material
Marginal discoloration
Time frame: From baseline to 24 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding Marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scorsese: Alfa: No discoloration. Bravo: Discoloration without. Charlie:Discoloration with penetration in pulpal direction
Marginal Adaptation
Time frame: From baseline to 24 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Seconder Caries
Time frame: From baseline to 24 month
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries presented. Charlie Caries present
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Background: PubMed 20305873Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.
- Background: PubMed 29153552Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.
- Related İnfoLink provided by the sponsor.
- 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.
Şükran Bolay, Prof. principal investigator
Hacettepe University
Taha Yasin Sarıkaya principal investigator
Hacettepe University
Onur Adson principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Margin Elevation (G-ænial Universal Injectable) in people with Dental Caries, 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 6 inclusion and 8 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 25 Jan 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?
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?
Retention (time frame: From baseline to 24 month). 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?
On the ClinicalTrials.gov record for NCT06222918, which also lists 2 linked publications.
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 25 Jan 2024.