Fracture of Lithium Disilicate (e.Max) CrownsNCT04054674
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
A study testing Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns in people with Fracture of Lithium Disilicate (e.Max) Crowns, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture of Lithium Disilicate (e.Max) Crowns
- What is being tested?
- Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 10 Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have no active periodontal diseases or periapical pathosis
- No tooth mobility or furcation involvement with sufficient occluso-gingival height
- Psychologically and physically able to withstand conventional dental procedures
- Patients with good endodontically treated teeth indicated for full coverage restorations
- Able to return for follow-up examination and evaluation
Who cannot join
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative
- Pregnant women that won't be able to come for follow-up visits
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
- Patients with poor root canal treatment
- Patients with parafunctional habits (eg. Bruxism)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes.
Read the detailed description
Statement of the problem:
The endodontically treated teeth need to be restored back to form, function and aesthetics. The quality of the coronal restoration will directly impact on their survival and success. The aim of the coronal restoration of endodontically treated teeth is to provide the necessary strength for the restoration/tooth complex through tooth preparation in order to withstand functional stress and prevent crown and/or root fracture. The use of ceramic crowns has increased substantially in recent years because of their superior esthetics and high mechanical properties. Long term success of all ceramic crowns is affected by many factors and the failure patterns of these all ceramic crowns should be inspected closely to detect their clinical performance.
Rationale for carrying out the trial:
Endodontic treatment weakens posterior teeth and ought to be covered by crowns.The capability of these crowns to bear load relies on the preparation of an appropriate design and the selection of a crown material with adequate fracture strength and thickness. In vital teeth, the anatomic occlusal preparation design is followed such that the occlusal surface is reduced uniformly, maintaining the cusps and normal inclined planes but at a reduced height. This aids in minimizing the risk of pulp injury. In contrast, in non-vital teeth, this design can be modified such that the occlusal surface is prepared in two planes (buccal and lingual planes). A flat prepared occlusal surface provides less quantitative and better qualitative stresses when compared to an anatomically prepared surface
- Being tested
- Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
- Keywords
- e.max, occlusal scheme, endodontically treated teeth
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abutments with flat occlusal scheme preparation restored by lithium disilicate crownsProcedure or surgery
Clinical trials lacks information about flat occlusal preparation design in case of endodontically treated teeth. Therefore, this is tested during preparation when compared to planer occlusal preparation while the final restoration in both arms is lithium disilicate (e.max) crowns.
| Study group | Role | What they receive |
|---|---|---|
| flat occlusal scheme restored by lithium disilicate crown | Experimental | flat occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns. Receives: Procedure: Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns |
| planar occlusal scheme restored by lithium disilcate crown | No intervention | planar occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring number of Fracture
using USPHS criteria for clinical evaluation
Measured: one year
Secondary outcomes (3)
Degree of Marginal adaptation
using USPHS criteria for clinical evaluation
Measured: one year
Degree of Marginal discoloration
using USPHS criteria for clinical evaluation
Measured: one year
Presence of Caries
using USPHS criteria for clinical evaluation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start10 Oct 2019
- Primary completion10 Jul 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Lithium Disilicate (e.Max) CrownsStudies of the same condition, open and under way.
- More trials run by Cairo 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054674
- Sponsor's protocol ID
- CEBC-CU-2019920
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2019
- Last updated
- 15 Apr 2022
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
- ClinicalTrials.gov ID
- NCT04054674
- Acronym / sponsor ID
- CEBC-CU-2019920
- Keywords
- e.max, occlusal scheme, endodontically treated teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 13 Aug 2019 (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 study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes.
Detailed description
Statement of the problem:
The endodontically treated teeth need to be restored back to form, function and aesthetics. The quality of the coronal restoration will directly impact on their survival and success. The aim of the coronal restoration of endodontically treated teeth is to provide the necessary strength for the restoration/tooth complex through tooth preparation in order to withstand functional stress and prevent crown and/or root fracture. The use of ceramic crowns has increased substantially in recent years because of their superior esthetics and high mechanical properties. Long term success of all ceramic crowns is affected by many factors and the failure patterns of these all ceramic crowns should be inspected closely to detect their clinical performance.
Rationale for carrying out the trial:
Endodontic treatment weakens posterior teeth and ought to be covered by crowns.The capability of these crowns to bear load relies on the preparation of an appropriate design and the selection of a crown material with adequate fracture strength and thickness. In vital teeth, the anatomic occlusal preparation design is followed such that the occlusal surface is reduced uniformly, maintaining the cusps and normal inclined planes but at a reduced height. This aids in minimizing the risk of pulp injury. In contrast, in non-vital teeth, this design can be modified such that the occlusal surface is prepared in two planes (buccal and lingual planes). A flat prepared occlusal surface provides less quantitative and better qualitative stresses when compared to an anatomically prepared surface
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flat occlusal scheme restored by lithium disilicate crown | Experimental | Procedure: Abutments with flat occlusal scheme preparation restored by lithium disilicate crownsflat occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns. |
| planar occlusal scheme restored by lithium disilcate crown | No intervention | –planar occlusal preparation of endodontically treated teeth is performed clinically and then the final restorations will be lithium disilicate (e.max) crowns. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have no active periodontal diseases or periapical pathosis
- No tooth mobility or furcation involvement with sufficient occluso-gingival height
- Psychologically and physically able to withstand conventional dental procedures
- Patients with good endodontically treated teeth indicated for full coverage restorations
- Able to return for follow-up examination and evaluation
Key exclusion criteria (8 listed)
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative
- Pregnant women that won't be able to come for follow-up visits
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
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 |
|---|---|---|
| Abutments with flat occlusal scheme preparation restored by lithium disilicate crownsClinical trials lacks information about flat occlusal preparation design in case of endodontically treated teeth. Therefore, this is tested during preparation when compared to planer occlusal preparation while the final restoration in both arms is lithium disilicate (e.max) crowns. | Procedure or surgery | flat occlusal scheme restored by lithium disilicate crown |
Primary outcome
Measuring number of Fracture
Time frame: one year
using USPHS criteria for clinical evaluation
3 secondary outcomes
Degree of Marginal adaptation
Time frame: one year
Degree of Marginal discoloration
Time frame: one year
Presence of Caries
Time frame: one year
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 15 Apr 2022.
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 Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns in people with Fracture of Lithium Disilicate (e.Max) Crowns, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 8 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 15 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 Egypt. 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?
Measuring number of Fracture (time frame: one year). 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 15 Apr 2022.