Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03298152
Status:
UNKNOWN
Last Update Posted:
2017-10-12
First Post:
2017-09-27
Brief Title:
One Year Clinical Evaluation of E-max CAD Versus Cerasmart Endocrowns in Anterior Endodontically Treated Teeth
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
One Year Clinical Evaluation of E-max CAD Versus Cerasmart Endocrowns in Anterior Endodontically Treated TeethA Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-10
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:
Nowadays Endocrowns are classified as conservative treatment modality for restoration of Endodontically treated teeth in which pulp chamber is used as a retentive resource
With the advancement in technology in the field of adhesive dentistry its use is increasing day by day in clinical practice Acid Etchable ceramics such as lithium Disilicate based ceramics are the gold standard ceramic material used for Endocrowns The Etchable property and the translucent character of lithium Disilicate enhance strength and esthetic property
A new material CERASMART Force Absorbing Flexible nano ceramic CADCAM block contain high density of ultrafine glass particles with 71 wt filled nano-composite It combines high strength and unique aesthetics full homogeneous and even distribution of nano ceramic network lead to unique physical properties for cerasmart Uniform scuttle very short inter-particle distance of silanated and bonded particles is key to delivering CERASMARTs with high strength and acceptable level of marginal adaptation
So it can perfectly use in posterior anterior inlay onlay and implant restorations and also enables minimum tooth reduction for more conservative restoration
Awad et al 1 found that Cerasmart showed significantly higher flexural strength and modulus of elasticity with lower flexural modulus values compared to other groups Also result in smoother margins compared with other types of ceramic
So present research will evaluate patient satisfaction bonding properties and marginal adaptation
With the advancement in technology in the field of adhesive dentistry its use is increasing day by day in clinical practice Acid Etchable ceramics such as lithium Disilicate based ceramics are the gold standard ceramic material used for Endocrowns The Etchable property and the translucent character of lithium Disilicate enhance strength and esthetic property
A new material CERASMART Force Absorbing Flexible nano ceramic CADCAM block contain high density of ultrafine glass particles with 71 wt filled nano-composite It combines high strength and unique aesthetics full homogeneous and even distribution of nano ceramic network lead to unique physical properties for cerasmart Uniform scuttle very short inter-particle distance of silanated and bonded particles is key to delivering CERASMARTs with high strength and acceptable level of marginal adaptation
So it can perfectly use in posterior anterior inlay onlay and implant restorations and also enables minimum tooth reduction for more conservative restoration
Awad et al 1 found that Cerasmart showed significantly higher flexural strength and modulus of elasticity with lower flexural modulus values compared to other groups Also result in smoother margins compared with other types of ceramic
So present research will evaluate patient satisfaction bonding properties and marginal adaptation
Detailed Description:
This study will carried out on patients collected from the dental clinics in fixed prosthodontics clinic Faculty of Dentistry Cairo University
the visits will be designed as follows
1st visit NN will call participants before tooth preparation procedure for X-ray reviewing and pre-operative photographing using a Professional digital camera also Impression will be taken using the alginate impression material for study cast analysis with suitable stock tray size
Each participant will be asked to sign consent form written in patient native language
2nd visit Tooth preparation After performing adequate disinfection and sterilization process for each instrument and tools will be used in this trial the anesthetic solution Anesthetic solution Septanest SP 4 Septodont France will be injected using infiltration technique Then patients will be left from five to ten minutes then the operator will check with the subjective for anasthesia
Full preparation will be carried out following the principles of Endocrown preparation with deep chamfer finish line while 2 observers will select visually the appropriate shade Final vinylpolysiloxane impressions will be taken for each participant in each groupusing the suitable tray size
After final setting impressions will be checked for accuracy using magnifying loops Magnifying loop Univet optical technologies Italy
Then protemp temporary endocrowns Temporary crown material Structure Voco GMBH Germany will be cemented using eugenol free Temporary cement RelyX Temp USA
Impressions will be sent to the lab poured with extra hard stone material Then it will be removed from the impression after complete setting
Endorowns for each patient will be fabricated using either lithium di-silicate material Emax or Cerasmart blocks according to the random allocation of the patients
3rd visit Participants will be called again for final cementation Temporary crown will be removed and abutments will be cleaned of any residues using pumice slurry Pumice slurry DCL Dental composite LTD England applied with bristle brush and rubber cup under water irrigation
Proper isolation will be done before cementation then permanent dual cure resin cement Permanent cement Bifix-QM Voco Gmbh Germany will be used for luting of permanent crowns according to manufacturer instructions Ask the patients to hold the crown under occlusal compression until luting cement polymerization 5 minutes later excess cement will be removed
Measuring of different outcomes will start in this visit for all patients
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
Visual inspection will be used for gross fracture evaluation Endorowns that intact and fully retained will be rated Alfa Endocrowns with partially retained with some portion of the restoration still intact will be rated as Bravoand endocrowns completely missing will be rated as Charlie
Visual inspection and explorer will be using for marginal integrity evaluation Endocrowns with no catch with The explorer and no visible crevice along the periphery of the restoration will be rated as Alpha A Endocrowns with explorer catches with visible evidence of a crevice with andor the base is not exposed and the restoration is not mobile will be rated as Bravo B and endocrowms with explorer penetrates and extended to the dento-enamel junction will be rated as Charlie
In addition questionnaires will be used to evaluate patients satisfaction and potential postoperative discomfort as the following questions
1 Are you satisfied with your endocrown appearance
2 Are you satisfied with your endocrown shade
3 Do you feel your endocrown are poorly aligned
4 Do you feel your endocrown are protruding
5 Are you hiding your teeth while smiling
Adherence improvement session will be taking place in the initial visit This session will include
Each patient will be informed about the study steps and maintain oral hygiene Subsequent sessions will occur at the follow-up visits
The patients will be trained for tooth brushing flossing and instructed all oral hygiene methods after each meal
Instruct the patients to record any abnormalities or mobility in endocrowns
Recall appointment will be performed every two months for aduration of one year to stress on oral hygiene
Data collection methods
Prosthodontic colleague will assess the outcome of each group Data will be collected on excel sheets All categorical data will be presented as risk ratios while numerical data will be presented by mean and standard deviation All data will be reported at a confidence interval of 95 and a p value of 5
Each factor will be measured as explained in the outcome table - Outcome results will be written down on the patients folders by NN then will be given to JG for data management All the information will be transferred on excel sheets and saved on a computer in safe place and locked with a password only known to JG A copy of the data will be saved on a flash drive with JG to provide a back up for the data
Plans to increase 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
JG will enter all data electronically Patient files are to stored in numerical order in a secured place JG and AZ will have access to data
Data Monitoring
AZ will be responsible of data monitoring if any lost or delete occurs in that case back up data will be taken from JG to provide hard copy for the requested data and AZ will make final decision
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
Auditing
Auditing of the study design will be done by AZ
Ethics and dissemination Research ethics approval Protocol and informed consent form will be reviewed by the Ethics Committee of Scientific Research - faculty of Dentistry - Cairo University
Protocol amendments
Any changes in protocol affect the conduct of the study benefit for patient or patient safety including changes in study objectives study design sample size study procedures or significant administrative aspect will require formal amendment to the protocol Such amendment will be agreed upon by the Council of Department of fixed prosthodontics Faculty of Dentistry Cairo University
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
Confidentiality
All information related to study will store securely All participants information will store in locked cabinets in areas with limited access To maintain participant confidentiality all data collection process and administrative forms will identify only by a coded ID number All information related to patient names or other personal identifiers will store separately identified by code number All local databases will be secured with password-protected access systems
Access to data
The investigator and supervisors 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 then might be used for further cohort study
Dissemination policy
o Study results will be published as partial fulfillment the Requirements for PHD degree in fixed prosthodontics
the visits will be designed as follows
1st visit NN will call participants before tooth preparation procedure for X-ray reviewing and pre-operative photographing using a Professional digital camera also Impression will be taken using the alginate impression material for study cast analysis with suitable stock tray size
Each participant will be asked to sign consent form written in patient native language
2nd visit Tooth preparation After performing adequate disinfection and sterilization process for each instrument and tools will be used in this trial the anesthetic solution Anesthetic solution Septanest SP 4 Septodont France will be injected using infiltration technique Then patients will be left from five to ten minutes then the operator will check with the subjective for anasthesia
Full preparation will be carried out following the principles of Endocrown preparation with deep chamfer finish line while 2 observers will select visually the appropriate shade Final vinylpolysiloxane impressions will be taken for each participant in each groupusing the suitable tray size
After final setting impressions will be checked for accuracy using magnifying loops Magnifying loop Univet optical technologies Italy
Then protemp temporary endocrowns Temporary crown material Structure Voco GMBH Germany will be cemented using eugenol free Temporary cement RelyX Temp USA
Impressions will be sent to the lab poured with extra hard stone material Then it will be removed from the impression after complete setting
Endorowns for each patient will be fabricated using either lithium di-silicate material Emax or Cerasmart blocks according to the random allocation of the patients
3rd visit Participants will be called again for final cementation Temporary crown will be removed and abutments will be cleaned of any residues using pumice slurry Pumice slurry DCL Dental composite LTD England applied with bristle brush and rubber cup under water irrigation
Proper isolation will be done before cementation then permanent dual cure resin cement Permanent cement Bifix-QM Voco Gmbh Germany will be used for luting of permanent crowns according to manufacturer instructions Ask the patients to hold the crown under occlusal compression until luting cement polymerization 5 minutes later excess cement will be removed
Measuring of different outcomes will start in this visit for all patients
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
Visual inspection will be used for gross fracture evaluation Endorowns that intact and fully retained will be rated Alfa Endocrowns with partially retained with some portion of the restoration still intact will be rated as Bravoand endocrowns completely missing will be rated as Charlie
Visual inspection and explorer will be using for marginal integrity evaluation Endocrowns with no catch with The explorer and no visible crevice along the periphery of the restoration will be rated as Alpha A Endocrowns with explorer catches with visible evidence of a crevice with andor the base is not exposed and the restoration is not mobile will be rated as Bravo B and endocrowms with explorer penetrates and extended to the dento-enamel junction will be rated as Charlie
In addition questionnaires will be used to evaluate patients satisfaction and potential postoperative discomfort as the following questions
1 Are you satisfied with your endocrown appearance
2 Are you satisfied with your endocrown shade
3 Do you feel your endocrown are poorly aligned
4 Do you feel your endocrown are protruding
5 Are you hiding your teeth while smiling
Adherence improvement session will be taking place in the initial visit This session will include
Each patient will be informed about the study steps and maintain oral hygiene Subsequent sessions will occur at the follow-up visits
The patients will be trained for tooth brushing flossing and instructed all oral hygiene methods after each meal
Instruct the patients to record any abnormalities or mobility in endocrowns
Recall appointment will be performed every two months for aduration of one year to stress on oral hygiene
Data collection methods
Prosthodontic colleague will assess the outcome of each group Data will be collected on excel sheets All categorical data will be presented as risk ratios while numerical data will be presented by mean and standard deviation All data will be reported at a confidence interval of 95 and a p value of 5
Each factor will be measured as explained in the outcome table - Outcome results will be written down on the patients folders by NN then will be given to JG for data management All the information will be transferred on excel sheets and saved on a computer in safe place and locked with a password only known to JG A copy of the data will be saved on a flash drive with JG to provide a back up for the data
Plans to increase 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
JG will enter all data electronically Patient files are to stored in numerical order in a secured place JG and AZ will have access to data
Data Monitoring
AZ will be responsible of data monitoring if any lost or delete occurs in that case back up data will be taken from JG to provide hard copy for the requested data and AZ will make final decision
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
Auditing
Auditing of the study design will be done by AZ
Ethics and dissemination Research ethics approval Protocol and informed consent form will be reviewed by the Ethics Committee of Scientific Research - faculty of Dentistry - Cairo University
Protocol amendments
Any changes in protocol affect the conduct of the study benefit for patient or patient safety including changes in study objectives study design sample size study procedures or significant administrative aspect will require formal amendment to the protocol Such amendment will be agreed upon by the Council of Department of fixed prosthodontics Faculty of Dentistry Cairo University
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
Confidentiality
All information related to study will store securely All participants information will store in locked cabinets in areas with limited access To maintain participant confidentiality all data collection process and administrative forms will identify only by a coded ID number All information related to patient names or other personal identifiers will store separately identified by code number All local databases will be secured with password-protected access systems
Access to data
The investigator and supervisors 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 then might be used for further cohort study
Dissemination policy
o Study results will be published as partial fulfillment the Requirements for PHD degree in fixed prosthodontics
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