Dental MaterialsNCT05707780
Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns
A study testing Resin-matrix, Monolithic zirconia and Metal-ceramic in people with Dental Materials, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dental Materials
- What is being tested?
- Resin-matrix, Monolithic zirconia and Metal-ceramic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2023to 30 Oct 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One posterior tooth (molar or premolar) to be crowned,
- Vital abutments or abutments with sufficient endodontic treatment
- Abutment not crowned previously
- Periodontally healthy abutments with no signs of bone resorption or periapical disease --
- Adequate occlusogingival height
- Stable occlusion, and the presence of natural dentition in the antagonist arch.
Who cannot join
- Patients who present reduced crown length (less than 3 mm occlusogingival height
- Poor oral hygiene, high caries activity, active periodontal disease or bruxism.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Odontology
Madrid, 28040
MARIA JESUS SUAREZ, PhD, 0034 913942029, mjsuarez@ucm.es
JESUS PELAEZ, PhD, 0034 913942029, jpelaezr@ucm.es
About this study
Official title: Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns
The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.
The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Read the detailed description
A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment
- Conditions
- Dental Materials
- Being tested
- Resin-matrix, Monolithic zirconia, Metal-ceramic
- Keywords
- crowns, monolithic zirconia, resin matrix ceramic, clinical evaluation, survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-matrixProcedure or surgery
Also called VarseoSmile crown
posterior crowns
Monolithic zirconiaProcedure or surgery
posterior crowns
Metal-ceramicProcedure or surgery
posterior crowns
| Study group | Role | What they receive |
|---|---|---|
| Resin-matrix ceramic | Experimental | To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow Receives: Procedure: Resin-matrix |
| Monolithic zirconia | Active comparator | To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow Receives: Procedure: Monolithic zirconia |
| Metal-ceramic | Active comparator | To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow Receives: Procedure: Metal-ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and success rates
Survival and success rates with Kaplan Meier method
Measured: 3 years
Secondary outcomes (21)
Quality of restorations at baseline
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Measured: Baseline
Quality of restorations at 1 year
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Measured: 1 year
Quality of restorations at 2 years
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Measured: 2 years
Quality of restorations at 3 years
The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Measured: 3 years
Plaque Index (PI) at baseline
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: Baseline
Plaque Index (PI) at 1 year
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 1 year
Plaque Index (PI) at 2 years
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 2 years
Plaque Index (PI) at 3 years
Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 3 years
Gingival Index (GI) at baseline
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: Baseline
Gingival Index (GI) at 1 year
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 1 year
Gingival Index (GI) at 2 years
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 2 years
Gingival Index (GI) at 3 years
Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome
Measured: 3 years
Probing depth at baseline
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Measured: Baseline
Probing depth at 1 year
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Measured: 1 year
Probing depth at 2 years
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Measured: 2 years
Probing depth at 3 years
Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome
Measured: 3 years
Margin stability at baseline
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: Baseline
Margin stability at 1 year
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 1 year
Margin stability at 2 years
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 2 years
Margin stability at 3 years
To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 3 years
Patient satisfaction at 3 years
Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possile result) to 10 (best possible result)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start25 Jan 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MaterialsStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- BEGO GmbH
- Responsible party
- Sponsor
- Investigators
- MARIA JESUS SUAREZ, PhD, Principal investigator, UNIVERSITY COMPLUTENSE OF MADRIDJESUS PELAEZ, PhD, Principal investigator, UNIVERSITY COMPLUTENSE OF MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707780
- Sponsor's protocol ID
- UCM
- Other IDs
- 4195120
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns
- ClinicalTrials.gov ID
- NCT05707780
- Acronym / sponsor ID
- UCM
- Conditions
- Dental Materials
- Keywords
- crowns, monolithic zirconia, resin matrix ceramic, clinical evaluation, survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- BEGO GmbH
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Feb 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 objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.
The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Detailed description
A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resin-matrix ceramic | Experimental | Procedure: Resin-matrixTo assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow |
| Monolithic zirconia | Active comparator | Procedure: Monolithic zirconiaTo assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow |
| Metal-ceramic | Active comparator | Procedure: Metal-ceramicTo assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- One posterior tooth (molar or premolar) to be crowned,
- Vital abutments or abutments with sufficient endodontic treatment
- Abutment not crowned previously
- Periodontally healthy abutments with no signs of bone resorption or periapical disease --
- Adequate occlusogingival height
Key exclusion criteria (2 listed)
- Patients who present reduced crown length (less than 3 mm occlusogingival height
- Poor oral hygiene, high caries activity, active periodontal disease or 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 |
|---|---|---|
| Resin-matrixAlso: VarseoSmile crownposterior crowns | Procedure or surgery | Resin-matrix ceramic |
| Monolithic zirconiaposterior crowns | Procedure or surgery | Monolithic zirconia |
| Metal-ceramicposterior crowns | Procedure or surgery | Metal-ceramic |
Primary outcome
Survival and success rates
Time frame: 3 years
Survival and success rates with Kaplan Meier method
21 secondary outcomes
Quality of restorations at baseline
Time frame: Baseline
Quality of restorations at 1 year
Time frame: 1 year
Quality of restorations at 2 years
Time frame: 2 years
Quality of restorations at 3 years
Time frame: 3 years
Plaque Index (PI) at baseline
Time frame: Baseline
Plaque Index (PI) at 1 year
Time frame: 1 year
Plaque Index (PI) at 2 years
Time frame: 2 years
Plaque Index (PI) at 3 years
Time frame: 3 years
Gingival Index (GI) at baseline
Time frame: Baseline
Gingival Index (GI) at 1 year
Time frame: 1 year
Gingival Index (GI) at 2 years
Time frame: 2 years
Gingival Index (GI) at 3 years
Time frame: 3 years
Probing depth at baseline
Time frame: Baseline
Probing depth at 1 year
Time frame: 1 year
Probing depth at 2 years
Time frame: 2 years
Probing depth at 3 years
Time frame: 3 years
Margin stability at baseline
Time frame: Baseline
Margin stability at 1 year
Time frame: 1 year
Margin stability at 2 years
Time frame: 2 years
Margin stability at 3 years
Time frame: 3 years
Patient satisfaction at 3 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Related trials for Dental Materials
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
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.
MARIA JESUS SUAREZ, PhD principal investigator
UNIVERSITY COMPLUTENSE OF MADRID
JESUS PELAEZ, PhD principal investigator
UNIVERSITY COMPLUTENSE OF MADRID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin-matrix, Monolithic zirconia and Metal-ceramic in people with Dental Materials, run by Universidad Complutense de Madrid at 1 site in Spain.
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 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 1 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 Spain. 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?
Contact MARIA JESUS SUAREZ, PhD (0034 913942029, mjsuarez@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival and success rates (time frame: 3 years). 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 1 Feb 2023.