Clinical BehavioralNCT06695091
Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations
A study testing Monolithic zirconia crown and Monolithic lithium disilicate crown in people with Clinical Behavioral, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Behavioral
- What is being tested?
- Monolithic zirconia crown and Monolithic lithium disilicate crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2020to 12 Dec 2025
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with posterior root canal treated teeth that require full coverage restoration.
- 20 - 50 years old.
- Males or Females.
- Good oral hygiene.
- Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
- Patients agreed to return to follow-up evaluation.
Who cannot join
- Active periodontal or pulpal diseases.
- Lack of opposing dentition.
- Severe medical complications.
- Pregnancy.
- Lack of compliance.
- Evidence of parafunctional habits
- Temporomandibular joint disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations (Randomized Clinical Trial)
The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).
- Conditions
- Clinical Behavioral
- Being tested
- Monolithic zirconia crown, Monolithic lithium disilicate crown
- Keywords
- Lithium disilicate, Zirconia, All-ceramic crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic zirconia crownProcedure or surgery
All-ceramic crown
Monolithic lithium disilicate crownProcedure or surgery
All-ceramic crown
| Study group | Role | What they receive |
|---|---|---|
| Flat occlusal scheme | Active comparator | occlusal design Receives: Procedure: Monolithic zirconia crown; Procedure: Monolithic lithium disilicate crown |
| Anatomic occlusal scheme | Active comparator | occlusal design Receives: Procedure: Monolithic zirconia crown; Procedure: Monolithic lithium disilicate crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Using Modified United States Public Health Service (USPHS) criteria
Measured: 12 months
Secondary outcomes (3)
Marginal adaptation
Using Modified United States Public Health Service (USPHS) criteria
Measured: 12 months
Marginal discoloration
Using Modified United States Public Health Service (USPHS) criteria
Measured: 12 months
Secondary caries
Using Modified United States Public Health Service (USPHS) criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start12 Sep 2020
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clinical BehavioralStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abou-steit, Cairo University
- Investigators
- Sameh Abou-Steit, Lecturer, Principal investigator, Lecturer of Fixed Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695091
- Sponsor's protocol ID
- CEBD-2020-9-120
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mannocci F, Cowie J. Restoration of endodontically treated teeth. Br Dent J. 2014 Mar;216(6):341-6. doi: 10.1038/sj.bdj.2014.198.
PubMed 24651340Varlan C, Dimitriu B, Varlan V, Bodnar D, Suciu I. Current opinions concerning the restoration of endodontically treated teeth: basic principles. J Med Life. 2009 Apr-Jun;2(2):165-72.
PubMed 20108535Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
PubMed 22259801Nagasiri R, Chitmongkolsuk S. Long-term survival of endodontically treated molars without crown coverage: a retrospective cohort study. J Prosthet Dent. 2005 Feb;93(2):164-70. doi: 10.1016/j.prosdent.2004.11.001.
PubMed 15674228Oyar P, Ulusoy M, Eskitascioglu G. Finite element analysis of stress distribution in ceramic crowns fabricated with different tooth preparation designs. J Prosthet Dent. 2014 Oct;112(4):871-7. doi: 10.1016/j.prosdent.2013.12.019. Epub 2014 Apr 21.
PubMed 24750896
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06695091
- Acronym / sponsor ID
- CEBD-2020-9-120
- Conditions
- Clinical Behavioral
- Keywords
- Lithium disilicate, Zirconia, All-ceramic crowns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 19 Nov 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 aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).
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 | Active comparator | Procedure: Monolithic zirconia crown, Procedure: Monolithic lithium disilicate crownocclusal design |
| Anatomic occlusal scheme | Active comparator | Procedure: Monolithic zirconia crown, Procedure: Monolithic lithium disilicate crownocclusal design |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with posterior root canal treated teeth that require full coverage restoration.
- 20 - 50 years old.
- Males or Females.
- Good oral hygiene.
- Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
Key exclusion criteria (7 listed)
- Active periodontal or pulpal diseases.
- Lack of opposing dentition.
- Severe medical complications.
- Pregnancy.
- Lack of compliance.
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 |
|---|---|---|
| Monolithic zirconia crownAll-ceramic crown | Procedure or surgery | Anatomic occlusal scheme, Flat occlusal scheme |
| Monolithic lithium disilicate crownAll-ceramic crown | Procedure or surgery | Anatomic occlusal scheme, Flat occlusal scheme |
Primary outcome
Fracture
Time frame: 12 months
Using Modified United States Public Health Service (USPHS) criteria
3 secondary outcomes
Marginal adaptation
Time frame: 12 months
Marginal discoloration
Time frame: 12 months
Secondary caries
Time frame: 12 months
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 Nov 2024.
- Background: PubMed 24651340Mannocci F, Cowie J. Restoration of endodontically treated teeth. Br Dent J. 2014 Mar;216(6):341-6. doi: 10.1038/sj.bdj.2014.198.
- Background: PubMed 20108535Varlan C, Dimitriu B, Varlan V, Bodnar D, Suciu I. Current opinions concerning the restoration of endodontically treated teeth: basic principles. J Med Life. 2009 Apr-Jun;2(2):165-72.
- Background: PubMed 22259801Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
- Background: PubMed 15674228Nagasiri R, Chitmongkolsuk S. Long-term survival of endodontically treated molars without crown coverage: a retrospective cohort study. J Prosthet Dent. 2005 Feb;93(2):164-70. doi: 10.1016/j.prosdent.2004.11.001.
- Background: PubMed 24750896Oyar P, Ulusoy M, Eskitascioglu G. Finite element analysis of stress distribution in ceramic crowns fabricated with different tooth preparation designs. J Prosthet Dent. 2014 Oct;112(4):871-7. doi: 10.1016/j.prosdent.2013.12.019. Epub 2014 Apr 21.
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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.
Sameh Abou-Steit, Lecturer principal investigator
Lecturer of Fixed Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monolithic zirconia crown and Monolithic lithium disilicate crown in people with Clinical Behavioral, 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 6 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 Nov 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 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?
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?
Fracture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695091, which also lists 5 linked publications.
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 Nov 2024.