The effect of simultaneous application of Bio-Oss and A-PRF on reducing the Period of treatment in Socket preservation.
Design
clinical trial,2 sided blind, with control group and randomized. 10 sample in each group.(total sample size is 20)
randomization of intervention sequence is done with 20 letter pocket containing equal number of control and test group titles.
Settings and conduct
after optimal anesthesia, tooth is extracted and with minimum flap reflection using less traumatic technique. Bio-Oss is applied to overfill the socket. Bio-Gide membrane is used to cover the socket. flap is sutured with 4-0 vicryl suture.
in test group A-PRF is mixed with Bio-Oss before it is applied.
after 3 month biopsy is harvested and implant is inserted.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study
1 - aged over 18 years
2. Healthy patients ASA 1 and 2
3. Periodontal health
4. Bone conditions : at least 50% of the bone support remain after the tooth is extracted.
5 - absence of any infection or periapical lesion
6 - absence of any uncontrolled systemic disease that compromise the healing process, such as uncontrolled diabetes
exclusion criteria for the study
1 - Patients with ASA III status or above
2. The presence of any uncontrolled systemic disease disrupts the recovery process, such as uncontrolled diabetes
3-Cigarette
4. Use of immunosuppressive drugs
5 - Radiotherapy history
6- pregnancy
7 - Removable prosthesis in the treatment area or adjacent to the target area
8 - spreading infection adjacent to the target area
Intervention groups
• Group 1:control:Biomaterial+barrier membrane
• Group 2:Test :Biomaterial+A-PRF+barrier Membrane
Main outcome variables
Ridge height, Ridge width, soft tissue closure time, new bone formation related to remnant bio material particles
General information
Reason for update
Acronym
A-PRF=Advanced platelet rich fibrin
IRCT registration information
IRCT registration number:IRCT20180416039329N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Armin Mirfasihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 1635
Email address
arminmirfasihi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
2019-01-10, 1397/10/20
Actual recruitment end date
2019-04-09, 1398/01/20
Trial completion date
2019-07-06, 1398/04/15
Scientific title
comparison of histologic, clinical and radiographic results of post extraction ridge preservation using xenogenic bone material with/without A-PRF
Public title
comparison of histologic, clinical and radiographic results of post extraction ridge preservation using xenogenic bone material with/without A-PRF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged over 18 years
Periodontal health
Healthy patients and ASAs 1 and 2, according to the American Cancer Society Association's classification system
absence of any infection or periapical lesion
Bone conditions such that at least 50% of the bone support remains after the tooth is extracted.(Necessity of Radiographic evaluation before surgery)
absence of any uncontrolled systemic disease that complicates the healing process, such as uncontrolled diabetes
Exclusion criteria:
Patients with ASA III status or above
presence of any uncontrolled systemic disease that complicatesthe the healing process, such as uncontrolled diabetes
smoker
Use of immunosuppressive drugs
Radiotherapy history
pregnancy
Removable prosthesis in the treatment area or adjacent to the dental socket area
spreading infection adjacent to the target area
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation software was used for simple randomization. after allocation in 2 groups with 10 participants, concealed in sequentially numbered, sealed, opaque envelopes were used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of shahid beheshti university of medial sciences
Street address
velenjak ave. chamran highway
City
tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.562
Health conditions studied
1
Description of health condition studied
ridge preservation-xenograft-Bio-Oss-PRF
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bone height
Timepoint
base time- 3 month
Method of measurement
CBCT (radiographic evaluation)
2
Description
Bone width
Timepoint
base time- 3 month
Method of measurement
CBCT (radiographic evaluation)
3
Description
ratio of 1-new bone formation to 2-remnant particles to 3-other non mineralized tissues
Timepoint
base time- 3 month
Method of measurement
histologic examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Bio-Oss group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is prepared with conventional method and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement.
Category
Treatment - Surgery
2
Description
Intervention group: Bio-Oss + A-PRF group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is mixed with A-PRF (by centrifuging the patient's blood) and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده دندان پزشکی شهید بهشتی
Full name of responsible person
دکتر آرمین میرفصیحی
Street address
no. 30-takhti street-fereshteh ave. vali asr street
City
tehran
Province
Tehran
Postal code
1965745411
Phone
+98 21 2203 5062
Email
arminmirfasihi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
معاونت پژوهشی دانشکده دندانپزشکی شهید بهشتی
Full name of responsible person
Dr.azita tehranchi
Street address
velenjak ave. chamran highway
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
arminmirfasihi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت پژوهشی دانشکده دندانپزشکی شهید بهشتی
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.Armin mirfasihi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
periodontology
Street address
no 30-takhti street-fershteh street-vali asr ave.
City
tehran
Province
Tehran
Postal code
1965745411
Phone
+98 21 2203 5411
Email
arminmirfasihi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Armin Mirfasihi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
periodontology
Street address
velenjak ave. chamran highway
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
arminmirfasihi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Armin mirfasihi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
periodontology
Street address
no 30-takhti street-fershteh street-vali asr ave.
City
tehran
Province
Tehran
Postal code
1965745411
Phone
+98 21 2203 5411
Email
arminmirfasihi@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
all information is accessable
When the data will become available and for how long
after publication
To whom data/document is available
all related fields
Under which criteria data/document could be used
bailment principles
From where data/document is obtainable
arminmirfasihi@yahoo.com
What processes are involved for a request to access data/document
sending request via email-evaluate-sending the information(1 month)