Endodontically Treated TeethNCT06311422
A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials
A study testing resin nanoceramic block and zirconia-reinforced lithium silicate in people with Endodontically Treated Teeth, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- resin nanoceramic block and zirconia-reinforced lithium silicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Good general health
- Patients older than 18
- Teeth must receive endodontic therapy before restoration
- The periodontal condition had to be stabilized before restoration
- No subject complained of discomfort in teeth
- Radiograph revealing alveolar bone resorption of less than a third and no shadow around the periapical tissues
- Participants who provided writen informed consent were recruited in collaboration
Who cannot join
- Any teeth with microcracks or fracture lines
- Affected teeth without completed root canal treatment
- The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
- Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
- Bruxism or clenching patients
- Poor general health or pregnancy
- Patients who have read the informed consent form and refused to be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry
Ankara, 06060
About this study
Official title: A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials Using The Computer-Aided Design/ Computer-Aided Manufacture (Cad/Cam) System
The clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.
- Conditions
- Endodontically Treated Teeth
- Being tested
- resin nanoceramic block, zirconia-reinforced lithium silicate
- Keywords
- CAD/CAM, Endocrown, resin nanoceramic, zirconia-reinforced lithium silicate
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resin nanoceramic blockOther
Also called Lava Ultimate block
Resin-based CAD/CAM materials
zirconia-reinforced lithium silicateOther
Also called Celtra Duo block
zirconia reinforced lithium silicate ceramic
| Study group | Role | What they receive |
|---|---|---|
| Lava Ultimate block | Experimental | Resin nanoceramic block Receives: Other: resin nanoceramic block |
| Celtra Duo block | Active comparator | zirconia-reinforced lithium silicate block Receives: Other: zirconia-reinforced lithium silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of two materials
36 months-Modified United States Public Health Service
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2020
- Primary completion15 Mar 2023
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Canatan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311422
- Sponsor's protocol ID
- CAD/CAM-endocrown
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different Materials Using The Computer-Aided Design/ Computer-Aided Manufacture (Cad/Cam) System
- ClinicalTrials.gov ID
- NCT06311422
- Acronym / sponsor ID
- CAD/CAM-endocrown
- Conditions
- Endodontically Treated Teeth
- Keywords
- CAD/CAM, Endocrown, resin nanoceramic, zirconia-reinforced lithium silicate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 15 Mar 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 clinical performance of two different materials in endodontically treated teeth produced with CAD/CAM system will be evaluated and compared. After obtaining a signed informed consert form from all the patients, all restorations will be placed by a single clinician. All endocrown restorations will be produced using the same CAD/CAM system. 52 restorations will be fabricated using Lava Ultimate (LU, 3M Espe, Seefeld, Germany) blocks and 38 restorations will be fabricated using Celtra Duo (CD, Dentsply Sirona, York, PA, USA) blocks. All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12,36, 48, 60 months. Descriptive statistics will be performed using Chi-square and Fisher exact test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lava Ultimate block | Experimental | Other: resin nanoceramic blockResin nanoceramic block |
| Celtra Duo block | Active comparator | Other: zirconia-reinforced lithium silicatezirconia-reinforced lithium silicate block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Good general health
- Patients older than 18
- Teeth must receive endodontic therapy before restoration
- The periodontal condition had to be stabilized before restoration
- No subject complained of discomfort in teeth
Key exclusion criteria (7 listed)
- Any teeth with microcracks or fracture lines
- Affected teeth without completed root canal treatment
- The defect was less than ¼ of crown or more than ¾ of the crown and the margin of the residual crown was more than 1 mm below the gingival level
- Poor oral hygiene and periodontal status which persisted or worsened after periodontal therapy and education
- Bruxism or clenching patients
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 nanoceramic blockAlso: Lava Ultimate blockResin-based CAD/CAM materials | Other | Lava Ultimate block |
| zirconia-reinforced lithium silicateAlso: Celtra Duo blockzirconia reinforced lithium silicate ceramic | Other | Celtra Duo block |
Primary outcome
Clinical performance of two materials
Time frame: 36 months
36 months-Modified United States Public Health Service
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Endodontically Treated Teeth
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Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
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Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Recruiting
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Root Canal Treated Posterior Teeth, Endodontically-Treated Teeth
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
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.
The record lists no contact. Use the official record to reach the sponsor.
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 nanoceramic block and zirconia-reinforced lithium silicate in people with Endodontically Treated Teeth, 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical performance of two materials (time frame: 36 months). 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 19 Mar 2024.