Dental MaterialsCerasmartNCT04995458
Clinical Evaluation of Composite-ceramic Implant-supported Posterior Crowns (Cerasmart)
A study testing composite-ceramic and Monolithic zirconia 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 analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Dental Materials
- What is being tested?
- composite-ceramic and Monolithic zirconia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2017to 20 Jun 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One posterior tooth (molar or premolar) to restore, and with opposing tooth
Who cannot join
- unacceptable oral hygiene
- bruxism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns
The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Read the detailed description
Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.
Eighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. 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. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.
- Conditions
- Dental Materials
- Being tested
- composite-ceramic, Monolithic zirconia
- Keywords
- implant-supported crowns, monolithic zirconia, composite-ceramic, clinical evaluation, survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite-ceramicProcedure or surgery
Also called Cerasmart
To assess the clinical performance of composite-ceramic crowns
Monolithic zirconiaProcedure or surgery
To assess the clinical performance of monolithic z¡irconia crowns
| Study group | Role | What they receive |
|---|---|---|
| Composite-ceramic | Experimental | To assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns Receives: Procedure: composite-ceramic |
| Monolithic zirconia | Active comparator | To assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns Receives: Procedure: Monolithic zirconia |
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 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: 2 years
Quality of restorations at 3 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: 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
Probing depth at baseline
Probing depth of the abutment. 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. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: 1 year
Probing depth at 2 year
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Measured: 2 years
Probing depth at 3 year
Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
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 posted9 Aug 2021
- Study start5 Jun 2017
- Primary completion20 Jul 2019
- Study completion20 Jun 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- GC Europe
- Responsible party
- Sponsor
- Investigators
- MARIA J SUAREZ, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995458
- Sponsor's protocol ID
- GC Europe N.V-4156360
- Acronym
- Cerasmart
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 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 Cerasmart Implant-supported Posterior Crowns
- ClinicalTrials.gov ID
- NCT04995458
- Acronym / sponsor ID
- Cerasmart / GC Europe N.V-4156360
- Conditions
- Dental Materials
- Keywords
- implant-supported crowns, monolithic zirconia, composite-ceramic, clinical evaluation, survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- GC Europe
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 9 Aug 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 analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Detailed description
Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.
Eighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. 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. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite-ceramic | Experimental | Procedure: composite-ceramicTo assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns |
| Monolithic zirconia | Active comparator | Procedure: Monolithic zirconiaTo assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- One posterior tooth (molar or premolar) to restore, and with opposing tooth
Key exclusion criteria (2 listed)
- unacceptable oral hygiene
- 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 |
|---|---|---|
| composite-ceramicAlso: CerasmartTo assess the clinical performance of composite-ceramic crowns | Procedure or surgery | Composite-ceramic |
| Monolithic zirconiaTo assess the clinical performance of monolithic z¡irconia crowns | Procedure or surgery | Monolithic zirconia |
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 year
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 year
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.
Probing depth at baseline
Time frame: Baseline
Probing depth of the abutment. 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. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 2 year
Time frame: 2 years
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 3 year
Time frame: 3 years
Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
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 composite-ceramic and Monolithic zirconia 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 1 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 16 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.