Tooth DefectNCT05346744
Occlusal Contact Trueness Affected by Six Chairside CAD/CAM Ceramic Materials
A study testing Chairside CAD/CAM ceramic materials for dental restoration in people with Tooth Defect, run by Fujian Medical University at 1 site in China.
Trial summary
The aim of this clinic self-control study was to evaluate the trueness of occlusal contact affected by six ceramic materials during chairside fabricating process and offer recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM design process. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Defect
- What is being tested?
- Chairside CAD/CAM ceramic materials for dental restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Aug 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- with one mandibular first molar requiring crown restoration that have undergone root canal treatment;
- with complete permanent dentition;
Who cannot join
- with carious lesions, abrasions, attrition, erosions or any kind of tooth defects;
- with any kind of restorations in occlusal surfaces;
- with any sign of temporomandibular dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Clinical Evaluation of the Occlusal Contact Trueness Affected by Six Chairside CAD/CAM Ceramic Materials：a Self-control Study
The aim of this clinic self-control study was to evaluate the trueness of occlusal contact affected by six ceramic materials during chairside fabricating process and offer recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM design process.
Read the detailed description
Ten participants were selected for this study. InCoris TZl(ZIR), Celtra Duo(CD), IPS e.max(EMA), UPCERA LICI (LC), Vita enamic(ENA), UPCERA RUNCI (RC) were used to produce crowns for everyone by CEREC chairside CAD/CAM system. The milling trueness, postprocessing trueness and clinical adjustment of occlusal contact were quantitatively analyzed by the ATOS high-precision scanner and Geomagic reverse engineering software.
- Conditions
- Tooth Defect
- Being tested
- Chairside CAD/CAM ceramic materials for dental restoration
- Keywords
- chairside CAD/CAM, ceramic materials, trueness, occlusal contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chairside CAD/CAM ceramic materials for dental restorationOther
6 crowns made from 6 chairside ceramic materials were milled by CEREC MCXL-EF mode for mandibular first molar of each participant.
The six materials are as follows:
ZIR: InCoris TZI (Dentsply Sirona, York, PA)， CD: Celtra Duo (Dentsply Sirona, York, PA), EMA: e.max CAD (ivoclar, Vivadent AG), LC: LiCi (UPCERA, China), ENA: Vita Enamic (Vita Zahnfabrik, Bad Sackingen, Germany) RC: RunCi (UPCERA, China)
| Study group | Role | What they receive |
|---|---|---|
| Zirconia | Experimental | 10 crowns made of zirconia from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
| Celtra Duo | Experimental | 10 crowns made of Celtra Duo from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
| e.max CAD | Experimental | 10 crowns made of e.max CAD from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
| Lici UPCERA | Experimental | 10 crowns made of Lici from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
| Enamic | Experimental | 10 crowns made of Enamic from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
| Runci UPCERA | Experimental | 10 crowns made of Runci from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. Receives: Other: Chairside CAD/CAM ceramic materials for dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
milling trueness(μm)
the absolute 3D deviation of occlusal contact points before and after milling
Measured: 1 week
postprocessing trueness(μm)
the absolute 3D deviation of occlusal contact points before and after postprocessing
Measured: 1 week
clinical trueness(μm)
the absolute 3D deviation of occlusal contact points before and after occlusal adjustment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Nov 2019
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DefectStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Ten individuals with tooth defect of mandibular first molar were selected to participate in the study. 6 crowns made from 6 chairside materials were milled by CEREC MCXL-EF mode for each mandibular first molar.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
- Investigators
- Hao Yu, Principal investigator, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346744
- Sponsor's protocol ID
- 2019028
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Clinical Evaluation of the Occlusal Contact Trueness Affected by Six Chairside CAD/CAM Ceramic Materials：a Self-control Study
- ClinicalTrials.gov ID
- NCT05346744
- Acronym / sponsor ID
- 2019028
- Conditions
- Tooth Defect
- Keywords
- chairside CAD/CAM, ceramic materials, trueness, occlusal contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Apr 2022 (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 clinic self-control study was to evaluate the trueness of occlusal contact affected by six ceramic materials during chairside fabricating process and offer recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM design process.
Detailed description
Ten participants were selected for this study. InCoris TZl(ZIR), Celtra Duo(CD), IPS e.max(EMA), UPCERA LICI (LC), Vita enamic(ENA), UPCERA RUNCI (RC) were used to produce crowns for everyone by CEREC chairside CAD/CAM system. The milling trueness, postprocessing trueness and clinical adjustment of occlusal contact were quantitatively analyzed by the ATOS high-precision scanner and Geomagic reverse engineering software.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- Ten individuals with tooth defect of mandibular first molar were selected to participate in the study. 6 crowns made from 6 chairside materials were milled by CEREC MCXL-EF mode for each mandibular first molar.
| Arm | Type | Receives |
|---|---|---|
| Zirconia | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of zirconia from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
| Celtra Duo | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of Celtra Duo from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
| e.max CAD | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of e.max CAD from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
| Lici UPCERA | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of Lici from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
| Enamic | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of Enamic from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
| Runci UPCERA | Experimental | Other: Chairside CAD/CAM ceramic materials for dental restoration10 crowns made of Runci from 10 individual were milled, post-processed and occlusal adjusted in patients' mouth. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- with one mandibular first molar requiring crown restoration that have undergone root canal treatment;
- with complete permanent dentition;
Key exclusion criteria (3 listed)
- with carious lesions, abrasions, attrition, erosions or any kind of tooth defects;
- with any kind of restorations in occlusal surfaces;
- with any sign of temporomandibular dysfunction.
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 |
|---|---|---|
| Chairside CAD/CAM ceramic materials for dental restoration6 crowns made from 6 chairside ceramic materials were milled by CEREC MCXL-EF mode for mandibular first molar of each participant. The six materials are as follows: ZIR: InCoris TZI (Dentsply Sirona, York, PA)， CD: Celtra Duo (Dentsply Sirona, York, PA), EMA: e.max CAD (ivoclar, Vivadent AG), LC: LiCi (UPCERA, China), ENA: Vita Enamic (Vita Zahnfabrik, Bad Sackingen, Germany) RC: RunCi (UPCERA, China) | Other | Celtra Duo, Enamic, Lici UPCERA, Runci UPCERA, Zirconia, e.max CAD |
Primary outcome
milling trueness(μm)
Time frame: 1 week
the absolute 3D deviation of occlusal contact points before and after milling
postprocessing trueness(μm)
Time frame: 1 week
the absolute 3D deviation of occlusal contact points before and after postprocessing
clinical trueness(μm)
Time frame: 1 week
the absolute 3D deviation of occlusal contact points before and after occlusal adjustment
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 26 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Hao Yu principal investigator
Fujian Medical 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 Chairside CAD/CAM ceramic materials for dental restoration in people with Tooth Defect, run by Fujian Medical University at 1 site in China.
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 3 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 26 Apr 2022. 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 China. 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?
milling trueness(μm) (time frame: 1 week). The study lists 3 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 26 Apr 2022.