Comparison of the strength of lithium disilicate hybrid abutments with titanium abutments in anterior implants of patients referred to Mashhad Dental School
Comparison of Lithium Dysilicate Hybrid Abutments and Conventional Abutments in a Clinical Trial
Design
A clinical trial with a control group with a parallel group - a randomized blind with simple method and Closed envelopes - with 10 samples in each group.
Settings and conduct
Methods: Based on the type of abutment used, patients referred to Mashahd Dental School are randomly divided into two groups: 1- Implants with titanium abutment and pfm coating Group 2: Implants with lithium disilicate abutment with Titanium base and solid ceramic coating
In both groups, the CAD / CAM device is used to make abutmentsTo design and manufacture abutments.
at the end, all patients follow up to examine the separation of the two abutment pieces or breaking the abutment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Single implant in the aesthetic area 2- Implant surgery should be two-stage 3- The type of implant should be bone level. 4. The patient has a normal occlusion
Exclusion criteria: 1- The patient has bruxism 2- The implant angle is more than 25 degrees. 3-gingival height less than 2 mm 4 - implant diameter less than 4 mm
Intervention groups
In the intervention group, lithium disilicate hybrid abutment is used
In the control group, common abutments are used
Main outcome variables
Ceramic abutment,
Fracture of ceramic abutments
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201019049072N1
Registration date:2020-11-30, 1399/09/10
Registration timing:retrospective
Last update:2020-11-30, 1399/09/10
Update count:0
Registration date
2020-11-30, 1399/09/10
Registrant information
Name
Ehsan Rastbood
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 3229
Email address
ehsan_rastbood@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-27, 1398/07/05
Expected recruitment end date
2020-02-26, 1398/12/07
Actual recruitment start date
2019-09-27, 1398/07/05
Actual recruitment end date
2020-02-26, 1398/12/07
Trial completion date
2020-09-28, 1399/07/07
Scientific title
Comparison of the strength of lithium disilicate hybrid abutments with titanium abutments in anterior implants of patients referred to Mashhad Dental School
Public title
Comparison of two fixed implants prosthetic methods on aesthetic zone in a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
single implant in esthetic zone
type of implant is bone level
implant surgery in two phases
patient has normal occlusion
Exclusion criteria:
patient has bruxism
angular of implant is higher than 25 degree
gingival height is less than 2 mm
diameter of implant is less than 4 mm
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to the School of Dentistry, Prosthodontics Department, after obtaining informed consent, are randomly divided (using sealed envelopes) into control and intervention groups.
20 envelopes in which the numbers one (meaning internal group) and number two (meaning control group) were written. Patients then select a sealed envelope, based on which the patient group is determined
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups based on randomization, but the patient does not know the type of treatment received, which includes the type of abutment. Abutments are not exposed to the patient before they are placed inside the mouth. Also, after the delivery of the crowns, the abutments are placed under the crowns and are not visible to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of mashhad university of medical science
Street address
vakilabad Blvd, ferdowsy university , dental collage
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.009
Health conditions studied
1
Description of health condition studied
Study different implant abutments
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Abutment breaking
Timepoint
The year after the restoration is completed
Method of measurement
View in the mouth
2
Description
debonding of abutment
Timepoint
The year after the restoration is completed
Method of measurement
View in the mouth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group with hybrid abutmentIn: this group of patients, they have a hybrid abutment (a type 4 titanium base with lithium di silicate coupling) for the implant crown
Category
Treatment - Devices
2
Description
Control group: In this group, patients have type 4 titanium abutment for implant crowns.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Mashhad university of medical science
Mashhad university of medical science, daneshgah st, Mashad. Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3255 3882
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan rastbood
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
ferdowsy university, dental collage ,Vakil abad Blvd, Mashad , Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
ehsan_rastbood@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
hossein dashti
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ferdowsy university, dental collage ,Vakil abad Blv
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
hossein_dashti@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Dashti
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar ave, Vakilabad Blvd, Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
3457234598
Phone
+98 51 3604 3229
Email
ehsan_rastbood@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After completing the study, the article prepared for it will be sent to prestigious scientific journals for publication
All data including sex, age, type of patient treatment, abutment fracture or fallout, and patient follow-up duration will be shared.
When the data will become available and for how long
About two months after the end of the study, the article will be sent for publication and immediately after the results are published, the researchers will have access to the documents.
To whom data/document is available
Access will be granted to both people working in academic and scientific institutions and people working in industry.
Under which criteria data/document could be used
It will be available for interested people
From where data/document is obtainable
Ways to access documents include sending messages and requesting documents via email:
ehsan_rastbood@yahoo.com.
What processes are involved for a request to access data/document
Upon request; The documents will be provided to the applicant about a week after the request.