Dental MaterialsNCT04943315
Clinical Evaluation of Monolithic Zirconia Crowns
A study testing 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 study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia posterior crowns. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dental Materials
- What is being tested?
- 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
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2019to 15 Jul 2023
- 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 75 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 abutment or abutment with an adequate endodontic treatment
- Abutment not crowned previously
- Periodontally healthy abutment with no signs of bone resorption or periapical disease.
- Adequate occlusogingival height ≥ 4 mm.
- Stable occlusion and the presence of natural antagonist tooth.
Who cannot join
- Patients who present reduced crown length (less than 4 mm occlusogingival height).
- Poor oral hygiene, high caries activity, or active periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Crowns
The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia 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
Seventy patients requiring at least one crown in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (MC) restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the crowns were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.
- Conditions
- Dental Materials
- Being tested
- Monolithic zirconia, Metal-ceramic
- Keywords
- crowns, metal-ceramic, monolithic zirconia, clinical evaluation, survival, wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic zirconiaProcedure or surgery
Also called Katana
posterior crowns
Metal-ceramicProcedure or surgery
posterior crowns
| Study group | Role | What they receive |
|---|---|---|
| Monolithic zirconia | Experimental | To assess the clinical performance and survival of posterior monolithic zirconia crowns Receives: Procedure: Monolithic zirconia |
| Metal-ceramic | Active comparator | To assess the clinical performance and survival of posterior metal-ceramic crowns Receives: Procedure: Metal-ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of restorations at baseline
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Measured: Baseline
Quality of restorations at 1 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Measured: 1 year
Quality of restorations at 2 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Measured: 2 years
Quality of restorations at 3 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Measured: 3 years
Plaque Index (PI) at baseline
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: baseline
Plaque Index (PI) at 1 year
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 1 year
Plaque Index (PI) at 2 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 2 years
Plaque Index (PI) at 3 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 3 years
Gingival Index (GI) at baseline
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: Baseline
Gingival Index (GI) at 1 year
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 1 year
Gingival Index (GI) at 2 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 2 years
Gingival Index (GI) at 3 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Measured: 3 years
Margin stability at baseline
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: Baseline
Margin stability at 1 year
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 1 year
Margin stability at 2 years
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 2 years
Margin stability at 3 years
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Measured: 3 years
Probing depth at baseline
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: Baseline
Probing depth at 1 year
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: 1 year
Probing depth at 2 years
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: 2 years
Probing depth at 3 years
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: 3 years
Patient satisfaction at 3 years
Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possible result) to10 (best possible result). The items analyzed were: esthetics, function, comfort, overall satisfaction
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 posted29 Jun 2021
- Study start6 May 2019
- Primary completion15 Dec 2020
- Study completion15 Jul 2023 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Kuraray Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Maria J Suarez, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943315
- Sponsor's protocol ID
- University Complutense Madrid
- Other IDs
- 4157246
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Crowns
- ClinicalTrials.gov ID
- NCT04943315
- Acronym / sponsor ID
- University Complutense Madrid
- Conditions
- Dental Materials
- Keywords
- crowns, metal-ceramic, monolithic zirconia, clinical evaluation, survival, wear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Kuraray Co. Ltd
- Study start
- 6 May 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 29 Jun 2021 (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 study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia posterior crowns. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Detailed description
Seventy patients requiring at least one crown in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (MC) restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the crowns were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monolithic zirconia | Experimental | Procedure: Monolithic zirconiaTo assess the clinical performance and survival of posterior monolithic zirconia crowns |
| Metal-ceramic | Active comparator | Procedure: Metal-ceramicTo assess the clinical performance and survival of posterior metal-ceramic crowns |
Who may qualify
- Ages
- 20 to 75 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 abutment or abutment with an adequate endodontic treatment
- Abutment not crowned previously
- Periodontally healthy abutment with no signs of bone resorption or periapical disease.
- Adequate occlusogingival height ≥ 4 mm.
Key exclusion criteria (2 listed)
- Patients who present reduced crown length (less than 4 mm occlusogingival height).
- Poor oral hygiene, high caries activity, or active periodontal disease
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 |
|---|---|---|
| Monolithic zirconiaAlso: Katanaposterior crowns | Procedure or surgery | Monolithic zirconia |
| Metal-ceramicposterior crowns | Procedure or surgery | Metal-ceramic |
Primary outcome
Quality of restorations at baseline
Time frame: Baseline
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 1 year
Time frame: 1 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 2 years
Time frame: 2 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Quality of restorations at 3 years
Time frame: 3 years
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Plaque Index (PI) at baseline
Time frame: baseline
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 1 year
Time frame: 1 year
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 2 years
Time frame: 2 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Plaque Index (PI) at 3 years
Time frame: 3 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at baseline
Time frame: Baseline
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 1 year
Time frame: 1 year
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 2 years
Time frame: 2 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 3 years
Time frame: 3 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Margin stability at baseline
Time frame: Baseline
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 1 year
Time frame: 1 year
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 2 years
Time frame: 2 years
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 3 years
Time frame: 3 years
To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)
Probing depth at baseline
Time frame: Baseline
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 1 year
Time frame: 1 year
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 2 years
Time frame: 2 years
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 3 years
Time frame: 3 years
Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Patient satisfaction at 3 years
Time frame: 3 years
Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possible result) to10 (best possible result). The items analyzed were: esthetics, function, comfort, overall satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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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.
Maria J Suarez, PhD study director
Universidad Complutense de 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 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 25 Jan 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?
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?
Quality of restorations at baseline (time frame: Baseline). The study lists 21 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 25 Jan 2023.