comparing the amount of marginal bone loss between bone-level and tissue-level implants in posterior site of mandible
Design
we randomly divided patients to two groups, getting different implant types. the implants were made by the same manufacturer and were placed by the same surgeon to avoid technical errors.
Settings and conduct
in this study all of the patients underwent surgery by the same surgeon and had received dental implants at the missing site of mandible. immediately after placement of implant, periapical radiography of the implant provided by parallel technique. also periapical radiographies provided after implant prothesis cementation and after 1-year follow-up. by comparing these radiographies, we measure and evaluate the amount of marginal bone loss
Participants/Inclusion and exclusion criteria
patients with missed teeth at the region of first or second mandibular molars
Intervention groups
we placed bone-level and tissue-level implants in two group of patients to replace missed mandibular molars
Main outcome variables
the implant type with less amount of marginal bone loss will be known as the better choice for replacing mandibular molars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051311N1
Registration date:2022-02-25, 1400/12/06
Registration timing:registered_while_recruiting
Last update:2022-02-25, 1400/12/06
Update count:0
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
roozbeh azadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7729 8679
Email address
roozbeh.azadi051@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-13, 1400/11/24
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the amount of marginal bone loss between bone-level and tissue-level implants in posterior site of mandible
Public title
comparing the amount of marginal bone loss between bone-level and tissue-level implants in posterior site of mandible
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with missed tooth at the region of first or second mandibular molars
Exclusion criteria:
Patients with systematic disorders
Smoker patients
Patients require bone grafting before implant surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly we use bone-level or tissue-level implants for patients. Patiens whom approved for implant placement, divided to two groups using random function of scientific calculator, creating numbers between 0 and 1. if the number is between 0 and 0.5 patient is assigned to bone level group, otherwise tissue level group is chosen.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of biomedical research of dental science of shahid beheshti medical university
Street address
shahid beheshti university of medical science - velenjak
City
تهران
Province
Tehran
Postal code
1985717443
Approval date
2022-02-12, 1400/11/23
Ethics committee reference number
IR.SBMU.DRC.REC.1400.155
Health conditions studied
1
Description of health condition studied
implant
ICD-10 code
M27.61
ICD-10 code description
Osseointegration failure of dental implant
Primary outcomes
1
Description
marginal bone loss
Timepoint
after prothesis cementation, after 1-year follow-up
Method of measurement
on parallel periapical radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: bone-level implant planting of ITI system (straumann) placed with conventional 2 stage surgery followed by cemented fixed prosthesis
Category
Treatment - Surgery
2
Description
Intervention group: tissue-level implant planting of ITI system (straumann) placed with conventional 2 stage surgery followed by cemented fixed prosthesis
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
dental office
Full name of responsible person
dr. Mehrdad Dehghanpour
Street address
Saadat abad
City
تهران
Province
Tehran
Postal code
0000000000
Phone
+98 21 2240 3075
Email
mdmehrdad26@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr Zarghi
Street address
Daneshjou blvd
City
تهران
Province
Tehran
Postal code
22439780
Phone
+98 21 2243 9780
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr Mehrdad Dehghanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjou blvd
City
تهران
Province
Tehran
Postal code
22439780081
Phone
+98 21 2243 9780
Email
mdmehrdad26@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr Mehrdad Dehghanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjou blvd
City
تهران
Province
Tehran
Postal code
22439780081
Phone
+98 21 2240 3075
Email
mdmehrdad26@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr Mehrdad Dehghanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
Daneshjou blvd
City
تهران
Province
Tehran
Postal code
22439780081
Phone
+98 21 2240 3075
Email
mdmehrdad26@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
the amount of marginal bone loss for each of patients will be revealed
When the data will become available and for how long
from the june of 2022
To whom data/document is available
no limitation
Under which criteria data/document could be used
no limitation
From where data/document is obtainable
to data update agent
What processes are involved for a request to access data/document