Evaluation of the effect of LPRF on the stiffness of the implant – bone interfce and primary stability in implants placed in edentulous posterior maxilla
Evaluation and comparison of initial stability and strength of the implant-bone interface in posterior maxillary implants and comparison of the marginal bone loss around the implant in parallel periapical radiography between the two groups of test and control
Design
15 patients who needed at least two implants in the posterior maxilla entered the study. During the surgery implants group were randomly determined by sealed envelope method and then Clinical and radiographic evaluations were performed in both groups during a 3-month follow-up period. The study was single blinded.
Settings and conduct
The study location was the implant department of the School of Dentistry, Tehran University of Medical Sciences. In each patient, in one surgical session, two implants were inserted. the examiner were blinded during the follow-up period. After a three-month follow-up period Periapical radiograph was taken.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients (over 18 years), systemically healthy, plaque index under 25%, there should be sufficient bone width and height in the desired area, there should be sufficient mesiodistal and interocclusal space. Exclusion criteria: Diabetes or any metabolic disease affecting bone metabolism, Pregnant women, People taking immunosuppressive drugs or corticosteroids, People with a history of radiotherapy or chemotherapy, and Patients with a history of surgery, bone grafting, or sinus floor augmentation.
Intervention groups
Placing blood derivatives on implants inserted in posterior maxilla and its effects on the initial stability and interface strength of implants compared to the implants without placing blood derivatives on the similar site.
Main outcome variables
Implant Stability Quotient ; Marginal bone loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200624047906N1
Registration date:2020-12-22, 1399/10/02
Registration timing:registered_while_recruiting
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Meshkat Naeimi darestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4342
Email address
meshkat_dnt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of LPRF on the stiffness of the implant – bone interfce and primary stability in implants placed in edentulous posterior maxilla
Public title
Evaluation of the effect of LPRF on the stiffness and stability of implants placed in posterior maxilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (over 18 years old)
healthy persons
overall plaque index under 25%
sufficient bone volume in vertical and horizontal lines
sufficient mesiodistal and interocclusal space
Exclusion criteria:
Diabetic patients or any other disease that affects bone metabolism
pregnant patients
people who use corticosteroids or other immune system suppressors
people who got bone graft or sinus floor augmentation previously
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, a sample is defined for the intervention group and a sample for the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the surgery, the test and control group is determined for each patient by using sealed envelopes (draw a pocket).
Blinding (investigator's opinion)
Single blinded
Blinding description
After surgery and suturing the area;The examiner clinician is asked to measure the ISQ of both the test and control sites and to obtain standard PA radiographs of both site and to determine the required values in them.It should be noted that after surgery, it is not possible to distinguish between the two groups, so the examiner is blinded to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, dental school,North karkar Ave.,Amir abad.,Tehran Town
City
Tehran
Province
Tehran
Postal code
1343856134
Approval date
2020-10-28, 1399/08/07
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.138
Health conditions studied
1
Description of health condition studied
Implant placement in edentulous site
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ISQ score
Timepoint
On the day of surgery immediately after implant placement and in the week 2-4-6-8-12 after surgery
Method of measurement
Osstell device
2
Description
The amount of marginal bone loss around implant
Timepoint
On the day of surgery immediately after implant placement and 12 weeks later
Method of measurement
Parallel periapical radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Placement of LPRF membrane obtained from 20 cc of patient venous blood on the implant before placement in bone during surgery
Category
Treatment - Surgery
2
Description
Control group: Implant placement in the bone in the usual way and without any additional intervention
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Implant Department, School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Meshkat naeimi darestani
Street address
School of Dentistry, Tehran University of Medical Sciences., North kargar Ave, Amir Abad
City
Tehran
Province
Tehran
Postal code
1343856134
Phone
+98 21 8835 1178
Email
Meshkat_dnt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meshkat naeimi darestani
Street address
Ebne sina Ave.,Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1343856134
Phone
+98 21 8835 1178
Email
Meshkat_dnt@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Meshkat naeimi darestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences., North kargar Ave., Amir abad
City
Tehran
Province
Tehran
Postal code
1343856134
Phone
+98 21 8835 1178
Email
Meshkat_dnt@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meshkat naeimi darestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences., North kargar Ave., Amir abad
City
Tehran
Province
Tehran
Postal code
1343856134
Phone
+98 21 8835 1178
Email
Meshkat_dnt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meshkat Naeimi Darestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences., North kargar., Amir abad
City
Tehran
Province
Tehran
Postal code
1343856134
Phone
+98 21 8835 1178
Email
Meshkat_dnt@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