Clinical evaluation of the effectiveness of 3 laboratory fabrication methods on marginal adaptation of metal-ceramic single crowns, which are impressed digitally
Clinical evaluation of marginal adaptation of the metal-ceramic single crowns impressed digitally and 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 that require crown reconstruction randomly divide into 3 intervention groups.After impressing digitally and preparing tooth by the dentist specialist, the restoration of each group is made in the laboratory. This restorations are examined before and after vinylation with 3 techniques for marginal adaptation:1-Parallel bite wing radiography 2-Touching the margins of crown using sonde 3-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 triple blind study, patients and researchers and evaluator and laboratorist do not know the details of the study and the method of randomization.
Participants/Inclusion and exclusion criteria
INCLUSION:1- Good general health 2- Periodontal health 3-No obvious sign or symptom of bruxism and/or clenching 4-Abutment requires reconstruction 5-Non-vital abutment teeth with positive long-term prognosis 6-Sufficient periodontal support for single crown restoration and minimum mobility 7-Sufficient tooth preparation length to ensure retention and resistance forms 8-Patients should be satisfied to join our study and sign the consent
EXCLUSION:1-Poor oral hygiene 2-Clinical sign and mobility(grade 2 and more) 3-Parafunctional habits 4-Periodontitis and severe gingivits
Clinical evaluation of the effectiveness of 3 laboratory fabrication methods on marginal adaptation of metal-ceramic single crowns, which are impressed digitally
Public title
Evaluation of single crowns marginal adaptation, fabricated in 3 different methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good general health (No systemic disease affecting the clinical outcomes)
Periodontal health (Plaque index and BOP should be under 20% before prosthodontic treatment)
No obvious signs or symptoms of bruxism and/or clenching (Bruxism such as attrition and fractures on the patient's natural tooth or reconstructions, no pain on muscular palpation or tendomyopathy, no pain due to joints, no self reported bruxism or clenching)
Abutment teeth requires reconstruction (abutment teeth with existing extensive cavities, fillings or crowns)
Non-vital abutment teeth with positive long-term prognosis based on clinical and radiological assessment (No obvious peri-apical or periodontal lesions)
Sufficient periodontal support for single crown restoration and minimum mobility
Sufficient tooth preparation length to ensure retention and resistance forms
Patients should be satisfied to join our study and sign the consent
Exclusion criteria:
Patients that are not willing or able to perform oral hygiene ( Plaque index and BOP more than 20%)
Abutment tooth with clinical signs
Tooth with grade two or more mobility
parafunctional habits
Periodontitis, severe gingivitis, poor oral hygiene and high active caries
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random allocation rule, 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 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)
Triple blinded
Blinding description
In this clinical trial study, the main researchers involved in, the prostodontic and student are blind to the assignment of each participant in each of the study groups. Participants in the study are blind toward their own group while 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.The Laboratorist is not also aware of each group assignment. 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
Ethic Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.KUMS.REC.1398.623
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 the restorations
Method of measurement
Adaptation is measured by using 3 methods: 1.Parallel bite wing radiography 2.Touching by a sonde 3. 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
Intervention group: Application of metal ceramic crowns fabricated by traditional and 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 st.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
hedaiat.mpradpour@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
faridnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah Univeristy 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
Hanieh Hamekhani
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry, shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
hanni.hamekhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hedaiat Moradpoor
Position
Assistant Professor of Prosthodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Prosthodontics, The School of Dentistry, Kermanshah University of Medical Siences, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3729 6910
Fax
+98 83 3729 1335
Email
h.moradpour@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hanieh Hamekhani
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, Shariati St.
City
Kermanshah
Province
Kermanshah
Postal code
67139546581
Phone
+98 83 3727 7030
Email
hanni.hamekhani@yahoo.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