Teeth, Endodontically-TreatedNCT03314545
Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
A study testing laminate veneer with coronal post and post,core and crown in people with Teeth, Endodontically-Treated and Anterior Teeth, run by Cairo University.
Trial summary
Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study" Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth, Endodontically-Treated, Anterior Teeth
- What is being tested?
- laminate veneer with coronal post and post,core and crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Jan 2020
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-60 years old, should be able to read and sign the consent document.
- Ability to tolerate the restorative procedures (physical and psychological).
- Patients with anterior endodontically treated teeth indicated for coronal restoration:
- Good oral hygiene
- Minimum remaining coronal tooth height of 4 mm
- Normal functional occlusal stresses within physiological limits.
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- Adequate crown/root ratio
- No signs and symptoms related to active periapical pathosis or endodontic failure.
- With no active periodontal or pulpal problems.
- Willing to return for follow-up visits.
Who cannot join
- Teeth not fully erupted as in young patients.
- Poor oral hygiene and lack of motivation
- Vital teeth
- Psychiatric problems or unrealistic expectations
- Excessive parafunctional stresses and bad habits like nail biting. 11
- The absence of sound enamel margins for the preparation
- Abnormally small teeth or with structural defects in enamel. 12
- Tooth mobility or inadequate crown/root ratio.
Trial locations and contacts
No sites are listed yet.
About this study
Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"
- Conditions
- Teeth, Endodontically-Treated, Anterior Teeth
- Being tested
- laminate veneer with coronal post, post,core and crown
- Keywords
- endocrown, laminate veneer with coronal post, post and core, crown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laminate veneer with coronal postProcedure or surgery
Also called anterior endocrown, endolam, endolaminate
laminate veneer with coronal post
post,core and crownProcedure or surgery
post,core and crown
| Study group | Role | What they receive |
|---|---|---|
| laminate veneers with coronal posts | Other | anterior endodontically treated teeth restored with laminate veneers with coronal posts Receives: Procedure: laminate veneer with coronal post |
| post, core and crown | Other | anterior endodontically treated teeth restored with post, core and crown Receives: Procedure: post,core and crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Fracture
: Alpha (A),Restoration is intact and fully retained. Bravo (B), Restoration is partially retained with some portion of the restoration still intact.
Charlie (C), Restoration is completely missing.
Measured: one year
Secondary outcomes (4)
marginal integrity
Alpha (A), Visual inspection and explorer, the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration. Bravo (B), Visual inspection and explorer, the explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile. Charlie (C), Explorer, the explorer penetrates crevice defect extended to the dentino-enamel junction.
Measured: one year
marginal discoloration
Alpha (A) Visual inspection, There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo (B), Visual inspection, There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. Charlie (C), Visual inspection, there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
Measured: one year
color match
Alpha (A) Visual inspection The restoration appears to match the shade and translucency of adjacent tooth tissues. Bravo (B), Visual inspection, the restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades. (Within normal range: Similar to silicate cement restorations for which the dentist did not quite succeed in matching tooth color by his choice among available silicate cement shades.) Charlie (C), visual inspection , the restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
Measured: one year
caries
Alpha (A) Visual inspection, the restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B), Visual inspection, there is visual evidence of dark deep discoloration adjacent to the restoration (but not directly associated with cavosurface margins).
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 posted19 Oct 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth, Endodontically-TreatedStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelrahman Elsadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314545
- Sponsor's protocol ID
- CEBD-CU-2017-09-32
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2017
- Last updated
- 19 Oct 2017
- 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 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
- ClinicalTrials.gov ID
- NCT03314545
- Acronym / sponsor ID
- CEBD-CU-2017-09-32
- Conditions
- Teeth, Endodontically-Treated, Anterior Teeth
- Keywords
- endocrown, laminate veneer with coronal post, post and core, crown
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Oct 2017 (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.
Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laminate veneers with coronal posts | Other | Procedure: laminate veneer with coronal postanterior endodontically treated teeth restored with laminate veneers with coronal posts |
| post, core and crown | Other | Procedure: post,core and crownanterior endodontically treated teeth restored with post, core and crown |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- From 18-60 years old, should be able to read and sign the consent document.
- Ability to tolerate the restorative procedures (physical and psychological).
- Patients with anterior endodontically treated teeth indicated for coronal restoration:
- With no active periodontal or pulpal problems.
- Willing to return for follow-up visits.
Key exclusion criteria (8 listed)
- Teeth not fully erupted as in young patients.
- Poor oral hygiene and lack of motivation
- Vital teeth
- Psychiatric problems or unrealistic expectations
- Excessive parafunctional stresses and bad habits like nail biting. 11
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 |
|---|---|---|
| laminate veneer with coronal postAlso: anterior endocrown, endolam, endolaminatelaminate veneer with coronal post | Procedure or surgery | laminate veneers with coronal posts |
| post,core and crownpost,core and crown | Procedure or surgery | post, core and crown |
Primary outcome
Gross Fracture
Time frame: one year
: Alpha (A),Restoration is intact and fully retained. Bravo (B), Restoration is partially retained with some portion of the restoration still intact. Charlie (C), Restoration is completely missing.
4 secondary outcomes
marginal integrity
Time frame: one year
marginal discoloration
Time frame: one year
color match
Time frame: one year
caries
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing laminate veneer with coronal post and post,core and crown in people with Teeth, Endodontically-Treated and Anterior Teeth, run by Cairo University.
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 10 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: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed Elsadek, MDS (002010052992472, m.elsadek@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross 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 19 Oct 2017.