An interventional study of E-max CAD endocrown and E-max CAd crowns retained with fiber reinforced composite post in Tooth Fractures and Debonding, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Among 10 studies in Tooth Fractures by Cairo University — 2 open to participants now, 2 under way, none of them phase 3. Tooth Fractures · Cairo University.
Among the 10 studies in Tooth Fractures by Cairo University, this one is the 6th largest by planned enrollment, is one of 4 that started in 2017, is one of 9 with no phase, and was the 4th registered.
37 studies on the registry are indexed under Tooth Fractures; 9 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 33 interventional studies indexed under Tooth Fractures.
Browse Tooth Fractures studies →2 of the 10 studies in Tooth Fractures by Cairo University are open now, in 1 country. Each count lists the studies.
Of the 5 Tooth Fractures studies recruiting now, 3 (60%) set no upper age limit and 1 (20%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 20 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2017.
Median enrollment 34 across the 10 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Tooth Fractures by Cairo University, from their registry updates:
Nothing recorded among them since 2026-09-25.
Different types of post and core have been used for several years for restoring anterior endodontically treated teeth, but their preparations involve various risks such as: root perforation, root weakness and tooth fracture. The introduction of adhesive systems and conservative restorations, make it possible to reconstruct damaged anterior endodontically treated teeth with conservative restoration as endocrowns. The hypothesis of this trial is that E-max CAD endocrowns will show comparably equal clinical performance if compared to E-max CAD crowns retained with fiber reinforced composite post and core system when treating anterior endodontically treated teeth..
This trial will be conducted on patients from the out patient clinic in the fixed prosthodontics clinic, Faculty of Oral and Dental Medicine, Cairo University.
The visits will be designed as follow:
st visit: (Y.A) will call participants before tooth preparation procedure for preoperative records, face to face adherence reminder session, clinical examination, radiograohic examination, pre-operative photographing, Impression taking for study cast analysis and waxing up. Each participant will be asked to sign consent form written in patient native language.
2nd visit: Tooth preparation for either e-max crown retained with fiber reinforced composie post or e-max endocrown, secondary impression and temporarization.
3rd visit: Try in of the restoration.
4th visit: Participants will be called again for final cementation.
5th visit: Follow up.
Sample size: 12 in each group to be able to reject the null hypothesis that the rates for case and controls are equal with probability (power) 0.8. This number is to be increased to 16 in each group to compensate for possible losses during follow up.
Recruitment: The patients fulfill inclusion criteria will be selected from dental clinics of the Fixed Prosthodontics Department - Cairo University (internal recruitment).
Screening of patients will carried out until target number is reached (consecutive sampling).
Methods: Assignment of interventions:
Sequence generation: Radi I (R.I) will allocate participants in two different groups with 1:1 allocation ratio by using computerized sequence generation (www.randomizer.org).
Implementation: IR will be responsible for provide allocation generation and save it in the envelopes in secured place until the date of performing procedure.
Plans to promote participant retention \& complete follow up: Telephone numbers of each patients and address will be taken and included in study, then phone calls and messages will be sent to remind patients before each appointment.
Data management: Guindy J (G.J) will enter all data electronically. Patient files are to stored in numerical order in a secured place in locked cabinets. G.J and Z.A will have access to data . Categorical data will be described as numbers and percentages. Data will be explored for normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. Comparisons between two groups for normally distributed numeric variables will be done using the Student's t-test while for non normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test. A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two tailed. Statistical Methods will be done using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL).
Data Monitoring: Z.A will be responsible of data monitoring if any lost or delete occurs, in that case: back up data will be taken from (G.J) to provide hard copy for the requested data for Z.A.
Harms: If 50% of the patients showed any unfavorable signs as sever pain, irreparable fracture or shade changes which might affect the results. Then the treatment will be considered as stopped guidelines which necessitate stopping the treatment and interim analysis will be performed.
Consent: Researcher will discuss the trial with all patients. Then patient can have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial. All consent forms will write in Arabic language (Appendix 1.1).
Access to data: The supervisors (Z.A and G.J) will give access to the data sets. All data sets will be protected by password. To ensure confidentiality, Participant study information will become confidentially.
Ancillary and post-trial care: All patients will be followed up 2 years even after the trial ends to report success of the treatments.
Dissemination policy: Study results will be published as partial fulfillment the Requirements for PHD degree in fixed prosthodontics.Topics suggested for presentation or publication will be circulated to the authors.
Data collection: The following assessment surveys (clinical evaluations) will done for both groups: All patients will be recalled after 3, 6, 9, and 12 months. For each recall examination, evaluator will performed the direct clinical evaluation using modified USPHS criteria for margin integrity and gross fracture. In addition, questionnaires will be used to evaluate patients' satisfaction and potential postoperative discomfort
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The modulus of elasticity of FRC post is (18-22 GPa) resembling that of dentin. Ideally the remaining tooth, the fiber post and the composite cement create a "monoblock" in which the loads are uniformly dissipated, ensuring a behavior similar to healthy teeth with a lower risk of root fracture. Using lithium disilicate e.max restorations is documented in literature as a successful restoration.
Procedure: E-max CAd crowns retained with fiber reinforced composite post
Endocrowns have several advantages over conventional crowns like adequate function and esthetic with less chair time reduced number of interfaces in the restorative system. Stress concentration is less because of the reduction in the nonhomogenous material present. The preparation design is conservative compared to the traditional crown. Supragingival margin prevents interferences with periodontal tissues so involvement of the biological width is minimal. The application and polymerization of resins is also better controlled. Emax ceramic material have a high mechanical strength and are capable of being acid etched, with the adhesive capacity of adhesive systems and resinous cements, made it possible to restore endodontically treated teeth, without cores and intraradicular posts.
Procedure: E-max CAD endocrown
endocrown used to restore endodontically treated teeth with E-max CAD endocrowns
fiber reinforced composite post need to restore endodontically treated tooth with E-max crown
Gross Fracture
it indicates if the restoration is intact and fully retained or not using USPHS criteria for recording Categorical 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
Time frame: 12 months
Patient Satisfaction
measured using Visual Analogue scale For Endocrowns:Are you satisfied with your endocrown appearance? Are you satisfied with your endocrown shade Do you feel your endocrown are poorly aligned? Do you feel your endocrown are protruding?Are you hiding your teeth while smiling? For E-max crowns retained with fiber reinforced composite post: Are you satisfied with your crown appearance? Are you satisfied with your crown shade?Do you feel your crown are poorly aligned? Do you feel your crown are protruding?Are you hiding your teeth while smiling
Time frame: 12 months
Marginal Integrity
Alpha (A):The explorer does not catch and no visible crevice along the periphery of the restoration.Bravo (B):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 ©: The explorer penetrates and extended to the dento-enamel junction.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Feb 2019, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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