Clinical evaluation of marginal adaptation of three-unit metal ceramic restoration fabricated using conventional impression technique and the new CAD/CAM technology in a randomized clinical trial study
Clinical evaluation of marginal adaptation of three-unit metal ceramic restoration fabricated using conventional impression technique and the new CAD/CAM technology in a randomized clinical trial study
Design
Clinical trial with parallel groups, double-blind, randomized, on 33 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients are visited at the dentist's office to assess the outcome. Part of the work is done in the research center laboratory, but the patient does not need to be present. Both the patient and the outcome assessor will be unaware of how the allocation process is done.
Participants/Inclusion and exclusion criteria
Periodontal health, Teeth: need restoration, have enough periodontal support, have sufficient length of preparation, have a positive long-term prognosis
The patient is willing to participate in our study
,
Systemic disease
Poor oral hygiene
Periodontitis, severe gingivitis and high caries activity
Obvious signs and symptoms of bruxism or clenching
Periodontal surgery required before preparation
Second or higher degree of mobility, clinical signs
Intervention groups
1. Includes 11 patients in which two basic teeth are examined in each patient. They receive the cobalt chrome three-unit restoration fabricated by the traditional casting method.
2. Includes 11 patients in which two basic teeth are examined in each patient. They receive the cobalt chrome three-unit restoration fabricated by CAD / Milling method from hard metal blocks.
3. Includes 11 patients in which two basic teeth are examined in each patient. They receive the cobalt chrome three-unit restoration fabricated by CAD / Ceramill Sintron method from soft metal blocks.
Main outcome variables
The main outcome includes marginal restoration compliance and the secondary consequences include internal and occlusal compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160213026538N7
Registration date:2022-01-28, 1400/11/08
Registration timing:prospective
Last update:2022-01-28, 1400/11/08
Update count:0
Registration date
2022-01-28, 1400/11/08
Registrant information
Name
Hedaiat Moradpoor
Name of organization / entity
Kermanshah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 6910
Email address
h.moradpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of marginal adaptation of three-unit metal ceramic restoration fabricated using conventional impression technique and the new CAD/CAM technology in a randomized clinical trial study
Public title
Clinical evaluation of marginal adaptation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Periodontal health, plaque index and BOP should be below 20% before prosthetic treatment
Abutment teeth require restoration
Abutment teeth Have enough periodontal support for three-unit restoration.
Abutment Teeth have sufficient length of preparation
Abutment teeth have a positive long-term prognosis
The patient is willing to participate in our study and sign the consent form
Exclusion criteria:
The patient has a systemic disease that affects clinical outcomes
The patient is unwilling or unable to maintain adequate oral hygiene
The patient has periodontitis, severe gingivitis and high caries activity
The patient has obvious signs and symptoms of bruxism or clenching
Abutment teeth require periodontal surgery before preparation
Abutment teeth have second or higher degree of mobility
Abutment teeth have clinical signs
Age
From 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers is used for randomization. In Excel software environment, four-digit codes are generated using the RANDBETWEEN command. Each patient is assigned a 4-digit code. If the last digit on the right is 1, 2 or 5, the patient is in the casting group, and if the last digit is 6, 3 or 8, the patient is assigned to the CAD Milling group. And if it is 7, 9 or 4, it is assigned to the CAD Ceramill Sintron group (Number zero is not considered). All codes are Written on papers and are kept in specific envelopes, which are randomly arranged. Registration and evaluation of entrance criteria is done by the secretary. When all the criteria for entering the study have been reviewed and the patient's information have been recorded, the secretary in charge of conducting the study will give one of these envelopes to the doctor. The doctor will decide on the treatment plan based on the specified code. Random sequencing is performed by a statistical and epidemiological consultant using Excel software.
The secretary only cooperates to conduct the study and has no information about the study hypothesis or the group codes. The outcome assessor also has no information on how patients are coded and assigned, but the doctor doing the assignment of intervention is aware of the group codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blinded trail. Patients will not be aware of the process of fabricating restorations and will also not be aware of which study group they are in. Also, the person in charge of evaluating the outcome has no information about how restorations are made. Therefore, both the patient and the outcome assessor will be unaware of how the allocation process is done
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences