Evaluation of soft tissue changes consequent to PRF usage in immediate implants for posterior teeth
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Settings and conduct
Patients were selected among clients of Implant Department and Dental Clinic of Mashhad dental university and then were randomized into two groups.The jumping gaps were filled with allograft in both groups.In the test group,we collected 9ml of blood from each patient in order to make PRF membranes(centrifuge at 2700rpm for 12min).We then used the PRF membranes to cover the sockets of posterior immediate implants.In the control group, we used CTG to cover the sockets of posterior immediate implants.Keratinized tissue width was measured at the time of surgery,1month and 3months after surgery.Keratinized tissue thickness was also measured at the time of surgery and 3months after the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Agreeable oral hygine(plaque index under 20%);partial edentulousness in posterior regions of the jaws;adequate bone quantity at the implant site;no need for periodontal surgery adjacent to the implant site;occlusal stability of the dentition
Exclusion criteria:Infection around implant site;history of bleeding disorders or anticoagulant therapy;immunocompromised state and debilitating diseases;severe systemic disease;tobacco use(more than 15 per day);drug addiction or alcoholism
Intervention groups
All patients were treated using the same implant system(implantium,bone level)
1.test: PRF as membrane+ allograft (MBA powder 500-1000µ,regen,Iranian tissue product co)
2.control: CTG without PRF+ allograft (MBA powder 500-1000µ,regen, Iranian tissue product co)
Comparison of soft tissue evaluation consequent to platelet rich fibrin( PRF) usage versus connective tissue graft in immediate posterior implants
Public title
Evaluation of platelet rich fibrin( PRF) effects on soft tissue changes in immediate implants for posterior teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good oral hygine(plaque index under 20%)
Partially edentolous on posterior region of jaw
Adequate bone quantity at the implant site
No need for periodontal surgery adjacent to the implant site
Occlusal stability of the dentition
Exclusion criteria:
Infection around implant site
History of bleeding disorder or anticoagulant therapy
Immunocompromised state and debilitating disease
Severe systemic disease
Tobacco use (more than 15 per day)
Drug addiction or alcoholism
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
in our study randomization take place using randomization.com website and random number has inserted in pocket.On the basis of the number in the pocket (even or odd), patients allocate to the test or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the current study, the surgeon and the patients were not able to be blinded due to the intervention including the usage of PRF in one group. Therefore, the assessor and the data analyzers were blinded.
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 Sciences
Street address
Vakil abad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.080
Health conditions studied
1
Description of health condition studied
periodontal disease
ICD-10 code
K13.22
ICD-10 code description
Minimal keratinized residual ridge mucosa
Primary outcomes
1
Description
Keratinized gingiva width
Timepoint
Baseline,1 month and 3 month after surgery
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
Keratinized gingiva thickness
Timepoint
Baseline and 3 month after surgery
Method of measurement
Periodontal probe
Intervention groups
1
Description
Intervention group: Jumping gap was filled with allograft (MBA powder 500-1000µ,regen,Iranian tissue product co). We collected 9ml of blood from each patient in order to make PRF membranes (centrifuge at 2700rpm for 12 min). We used the PRF membranes to cover the sockets of posterior immediate implants. Keratinized tissue width was measured at the time of surgery, 1month and 3 months after the surgery. Keratinized tissue thickness was measured at the time of surgery and 3 months after the surgery.
Category
Treatment - Surgery
2
Description
Control group: Jumping gap was filled with allograft (MBA powder 500-1000µ,regen,Iranian tissue product co). CTG (harvested from palate) was used to cover the sockets of posterior immediate implants. Keratinized tissue width was measured at the time of surgery,1month and 3 months after the surgery. Keratinized tissue thickness was measured at the time of surgery and 3 months after the surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Mounes Jamali
Street address
Vakilabad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3846 0502
Email
jamalim971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Zare Mahmoodabadi
Street address
Vakil abad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
Email
jamalim971@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
Mounes Jamali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
jamalim971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mounes Jamali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
jamalim971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mounes Jamali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil abad Blvd, Mashhad dental faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7257
Email
jamalim971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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