Pulp Disease, DentalNCT03542019
Survival of Endocrowns Made From Different Ceramics
A study testing Dental prosthesis, Dental crown and Hybrid ceramic in people with Pulp Disease, Dental and Dental Caries, run by University of Jordan at 1 site in Jordan.
Trial summary
Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulp Disease, Dental, Dental Caries, Dental Leakage
- What is being tested?
- Dental prosthesis, Dental crown and Hybrid ceramic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Root canal treated molars with significant loss of tooth structure
- Supra-gingival margins
- Teeth scheduled for cuspal-covering indirect restorations
Who cannot join
- Teeth with extensive cracks or fractures
- Teeth with deep subgingival margins
- Non-functional teeth (no opposing dentition)
- Teeth with advanced periodontitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.
Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.
- Conditions
- Pulp Disease, Dental, Dental Caries, Dental Leakage
- Being tested
- Dental prosthesis, Dental crown, Hybrid ceramic
- Medical subject headings
- Dental Pulp Diseases, Dental Caries, Dental Leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental prosthesisDevice
Also called Crowns
Replacement of missing tooth structure using Lithium disilicate porcelain
Dental crownDevice
Also called Endocrown
Replacement og missing tooth structure using monolithic zirconia
Hybrid ceramicDevice
Also called Indirect restoration
Restroration of endodontically treated teeth using hybrid ceramic
| Study group | Role | What they receive |
|---|---|---|
| Lithium disilicate | Active comparator | Lithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns Receives: Device: Dental prosthesis |
| Monolithic zirconia | Active comparator | Monolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns Receives: Device: Dental crown |
| Hybrid ceramic | Active comparator | Hybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns Receives: Device: Hybrid ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of Dental Prosthesis
The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- 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
- Model description
- Three different ceramic types for restoration of endodontically treated teeth
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad El-Ma'aita, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542019
- Sponsor's protocol ID
- 10/2017/25289
- Status last verified
- Oct 2021
- First submitted
- 1 Apr 2018
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Endocrown; a Prospective Randomised Clinical Trial of Three Different Ceramics
- ClinicalTrials.gov ID
- NCT03542019
- Acronym / sponsor ID
- 10/2017/25289
- Conditions
- Pulp Disease, Dental, Dental Caries, Dental Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.
Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three different ceramic types for restoration of endodontically treated teeth
| Arm | Type | Receives |
|---|---|---|
| Lithium disilicate | Active comparator | Device: Dental prosthesisLithium disilicate: a type of ceramic material used to make a dental prosthesis that replaces missing tooth structure following root canal treatment. Other names might include: E-max crowns, computer-aided design and computer-aided manufacturing (CAD CAM) crowns |
| Monolithic zirconia | Active comparator | Device: Dental crownMonolithic zirconia: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Zolid crown, Bruxzir, Bretau, CAD CAM crowns |
| Hybrid ceramic | Active comparator | Device: Hybrid ceramicHybrid ceramic: a type of ceramic material used to make a dental prosthesis that replaces the missing tooth structure following root canal treatment. Other names might include: Enamec, Lava Ultimate, CAD CAM crowns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Root canal treated molars with significant loss of tooth structure
- Supra-gingival margins
- Teeth scheduled for cuspal-covering indirect restorations
Key exclusion criteria (4 listed)
- Teeth with extensive cracks or fractures
- Teeth with deep subgingival margins
- Non-functional teeth (no opposing dentition)
- Teeth with advanced periodontitis
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 |
|---|---|---|
| Dental prosthesisAlso: CrownsReplacement of missing tooth structure using Lithium disilicate porcelain | Device | Lithium disilicate |
| Dental crownAlso: EndocrownReplacement og missing tooth structure using monolithic zirconia | Device | Monolithic zirconia |
| Hybrid ceramicAlso: Indirect restorationRestroration of endodontically treated teeth using hybrid ceramic | Device | Hybrid ceramic |
Primary outcome
Survival of Dental Prosthesis
Time frame: 24 months
The endocrowns (the dental prosthesis studied) were assessed after 24 months. Those that were functional and without any symptoms were considered surviving.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Dental prosthesis, Dental crown and Hybrid ceramic in people with Pulp Disease, Dental and Dental Caries, run by University of Jordan at 1 site in Jordan.
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 3 inclusion and 4 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 4 Nov 2021. 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 Jordan. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival of Dental Prosthesis (time frame: 24 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 4 Nov 2021.