Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03331887
Status:
UNKNOWN
Last Update Posted:
2017-11-07
First Post:
2017-10-29
Brief Title:
E-max CAD Crowns Retained With Fiber Reinforced Composite Post Versus E-max CAD Endocrowns
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
One Year Clinical Evaluation of E-max CAD Crowns Retained With Fiber Reinforced Composite Post Versus E-max CAD Endocrowns in Anterior Endodontically Treated Teeth A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Adherence session will take place in the presence of the patients in the initial visit This include that the patients will be informed by Abou El-Enein Y about the study steps and maintenance of oral hygiene instructions Participant will be asked by Abou El-Enein Y if they have any problem like pain
Motivation and enforcing the maintenance of oral hygiene measures by Abou El-Enein Y
The visits will be designed as follow
st visit YA 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 08 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 RI will allocate participants in two different groups with 11 allocation ratio by using computerized sequence generation wwwrandomizerorg
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 GJ will enter all data electronically Patient files are to stored in numerical order in a secured place in locked cabinets GJ and ZA 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 Students 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 005 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 ZA will be responsible of data monitoring if any lost or delete occurs in that case back up data will be taken from GJ to provide hard copy for the requested data for ZA
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 11
Access to data The supervisors ZA and GJ 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 prosthodonticsTopics 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
Adherence session will take place in the presence of the patients in the initial visit This include that the patients will be informed by Abou El-Enein Y about the study steps and maintenance of oral hygiene instructions Participant will be asked by Abou El-Enein Y if they have any problem like pain
Motivation and enforcing the maintenance of oral hygiene measures by Abou El-Enein Y
The visits will be designed as follow
st visit YA 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 08 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 RI will allocate participants in two different groups with 11 allocation ratio by using computerized sequence generation wwwrandomizerorg
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 GJ will enter all data electronically Patient files are to stored in numerical order in a secured place in locked cabinets GJ and ZA 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 Students 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 005 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 ZA will be responsible of data monitoring if any lost or delete occurs in that case back up data will be taken from GJ to provide hard copy for the requested data for ZA
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 11
Access to data The supervisors ZA and GJ 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 prosthodonticsTopics 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None