clinical evaluation of the marginal adaptation of metal ceramic single unit crowns fabricated by lost wax technique and new Computer Aided Design/Computer Aided Manufacturing technologies
clinical determining of marginal adaptation of metal ceramic single unit restorations fabricated by lost wax technique and CAD/CAM with new technology
Design
In this study,60 abutment teeth in need of crown reconstruction that have inclusion criteria and come to Kermanshah dental college were randomly assigned to intervention groups.
Settings and conduct
abutment teeth in need of crown recinstruction are randomly divided into 3 intervention groups.After the teeth are prepared by the dentist specialist, the restoration of each group is made in the laboratory. This restoration is examined for the time before and after vinylation with 3 techniques for marginal adaptation:1-bite wing radiography2-Touching the margins of crown using sonde3-silicone replica technique:In this technique, after molding the space between the crown and abutment tooth using silicone, the specimens are measured under a stereomicroscope.In this double blind study, patients and researchers do not know the details of the study and the method of randomization.
Participants/Inclusion and exclusion criteria
INCLUSION:1- good general health2- periodontally healthy3- no obvious signs or symptoms of bruxing and/or clenching 4-abutment teeth in need of reconstruction5-non-vital abutment teeth with positive long-term prognosis uponclinical and radiological assessment 6-the tooth should have enough periodontal support for single unit restoration an also minimal mobility7- the tooth should have enough preparation length to ensure the retention and resistance forms 8-the patient is ready to take part in the study and sign the testimonial
EXCLUSION:1-poor oral hygiene2-clinical sign and mobility(grade 2 and more)3-parafunctional habits4-periodontitis and severe gingivits
clinical evaluation of the marginal adaptation of metal ceramic single unit crowns fabricated by lost wax technique and new Computer Aided Design/Computer Aided Manufacturing technologies
Public title
evaluation of the marginal adaptation of single unit crowns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
good general health(no systemic disease that should negatively influence the clinical outcome)
periodontally healthy(plaque index and bleeding on probing had to be below 20% previously to the prosthodontic treatment)
no obvious signs or symptoms of bruxing and/or clenching((bruxismsuch as attritions and existing fractures on the patientsnatural teeth or reconstructions, no pain on muscular palpationor tendomyopathies, no pain causing joint sound, no selfreportedbruxing or clenching)
abutment teeth in need of reconstruction (abutment teeth withexisting extensive cavities, fillings or crowns)
non-vital abutment teeth with positive long-term prognosis uponclinical and radiological assessment (no peri-apical or apparentperiodontal lesions)
the tooth should have enough periodontal support for single unit restoration an also minimal mobility
the tooth should have enough preparation length to ensure the retention and resistance forms
the patient is ready to take part in the study and sign the testimonial
Exclusion criteria:
The patient is not willing or able to observe oral hygiene ( Plaque index and BOP should be below 20%).
The abutment tooth has clinical sign.
The tooth has grade two or more mobility.
parafunctional habits
Periodontitis, severe gingivitis, poor oral hygiene and high caries activity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random allocation law, after determining 60 maxillary and mandibular first molars based on statistical calculations, 20 cards for the Casting group, 20 cards for the CAD/Milling group, and 20 cards for the CAD/Ceramill Sintron group will be placed in a draw glass, then the cards will be dropped out randomly and without replacement and the resulting sequence will be recorded. Then, 60 envelopes are prepared and each random sequence created is recorded on a card and the cards are inserted into the envelope respectively. In order to maintain a random sequence, the envelopes are numbered to the same. In the end, the door covers are enclosed in boxes and placed in a box respectively. At the time of the start of the registration of the participants, according to the order of entry of qualified participants to study, one of the envelopes are opened in sequence and the participant's assigned group is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this clinical trial study, the main researchers involved in the prostodontics and students are blind to the assignment of each participant in each of the study groups. Participants in the study are blind toward their own group when they are aware of the similar costs and benefits of clinical treatments based on studies. Also the result analyst and the outcome evaluator, have no information about the data of each group. Only a health care worker knows about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.KUMS.REC.1396.531
Health conditions studied
1
Description of health condition studied
marginal adaptation of single unit restorations
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
marginal adaptation of restorations
Timepoint
before and after veneering of restorations
Method of measurement
adaptation is measured using 3 methods:1-parallal bite wing radiography2-touch using a sonde3-silicone replica technique
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: application of metal ceramic crowns fabricated by CAD/Milling technique
Category
Treatment - Devices
2
Description
Intervention group: application of metal ceramic crowns fabricated by CAD/Ceramill Sintron
Category
Treatment - Devices
3
Description
Control group: application of metal ceramic crowns fabricated by traditional wax removal
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
kermanshah dental university
Full name of responsible person
Hedaiat Moradpour
Street address
Shariati Street
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
hedaiat.moradpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3729 6591
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahsa Samavati
Position
Under graduated Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
سایر حوزههای کاری/تخصصها آدرس خیابان The school of Dentistry, shariati Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3845 0641
Email
m93samavati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hedaiat Moradpour
Position
asisstant professor of prosthodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariaty street
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
hedaiat.moradpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahsa Samavati
Position
Under graduated Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3845 0641
Email
m93samavati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available