determination of implant stability, alveolar ridge dimensions, and bone density immediately and 6 months after implants with the use of injectable platelet-rich fibrin and Allograft or Allograft solely.
Design
A phase 2 clinical trial with the control group, with parallel groups, without blinding on 20 patients
Settings and conduct
After the evaluation of the patient's radiography and inclusion criteria in patients in the hospital of Mashhad University of Medical Sciences in need of immediate implants in the anterior region, patients will be divided into two groups with respect to the patient's age and sex, and the position of the implant. informed consent will be taken from patients. 10 ml of whole blood will be taken from the intervention group and i-prf will be made and combined with allograft for filling the buccal gap. 2 CBCT will be taken from the implant region immediately and 6 months after implantation. bone density and dimension of buccal bone, and implant stability will be measured. outcome assessors will be blinded.
Participants/Inclusion and exclusion criteria
Including criteria:
1) one root tooth (mandible or maxilla) because of trauma, decay, root degeneration
2) Limitation of 20-year-old
3) space between sucket and fixture is equal to or more than 2 mm in one-third of the cranial sucket
Excluding criteria:
1) Severe rage atrophy
2) active infection (periodontitis, or mucosal infection)
3) radiotherapy diseases or chemotherapy
Intervention groups
Intervention group: 10 patients who after implant, allograft with platelet-rich fibrin was used in the regeneration of buccal defect.
Control group: 10 patients who after implant, allograft without platelet-rich fibrin was used in the regeneration of buccal defect
Main outcome variables
implant stability, bone density, dimensions of buccal bone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220407054448N1
Registration date:2022-05-08, 1401/02/18
Registration timing:retrospective
Last update:2022-05-08, 1401/02/18
Update count:0
Registration date
2022-05-08, 1401/02/18
Registrant information
Name
Mahsa َAhmadi Shadmehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 4195
Email address
mhs.ahmadishadmehri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-09, 1400/12/18
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
2022-03-10, 1400/12/19
Actual recruitment end date
2022-04-14, 1401/01/25
Trial completion date
empty
Scientific title
Evaluation of the effect of i-prf and Allograft bone substitute combination in bone regeneration around immediate implants with buccal bone dehiscence
Public title
Platelet-rich fibrin in immediate implants with buccal bone defect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
hopeless single root teeth extracted due to trauma, caries, resorption and root fracture
age over 20 years old
good oral hygiene : FMBS,FMPS < 25%
Buccal gap between socket wall and fixture more than 2 mm plus a small dehiscence defect in buccal
healthy soft tissue
Exclusion criteria:
severe atrophy of ridge
active infection (on periodontium or mucosa)
patient with history of radiotherapy or chemotherapy
use of alcohol or cigarrete more than 10 pieces a day
patient with systemic disorders ( uncontrolled diabetes, autoimmune disorders, etc..)
pregnancy
patient with bone, or hematologic disorders
presence of periapical pathology which involves adjacent teeth
Age
From 20 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)
Not randomized
Randomization description
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 islamic azad university of isfahan (khorasgan Branch)
Street address
arghavanieh blv
City
isfehan
Province
Isfehan
Postal code
81551-39998
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.355
Health conditions studied
1
Description of health condition studied
Buccal bone defect
ICD-10 code
M27.8
ICD-10 code description
Other specified diseases of jaws
Primary outcomes
1
Description
dimension of buccal bone plate
Timepoint
6 months from immediate implantation
Method of measurement
cone beam computed tomography (CBCT)
2
Description
bone density
Timepoint
6 months from immediate implantation
Method of measurement
cone beam computed tomography (CBCT)
3
Description
implant stability value
Timepoint
6 months from immediate implantation
Method of measurement
periotest device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 patients who after implanting, allograft with platelet-rich fibrin was used in buccal defect regeneration.
Category
Treatment - Surgery
2
Description
Control group: 10 patients who after implanting, allograft without platelet-rich fibrin was used in buccal defect regeneration.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
periodontics department of dental school of islamic azad university of isfahan (khorasgan branch)
Full name of responsible person
vahid esfahanian
Street address
islamic azad university of isfahan(khorasgan branch) arghavanie ave., Jey blv., isfahan, Iran
City
isfehan
Province
Isfehan
Postal code
81551-39998
Phone
+98 936 668 9455
Email
mhs.ahmadishadmehri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
vahid esfahanian
Street address
islamic azad university of isfahan (khorasgan branch),.arghavanieh ave., jey blv., isfahan.
City
isfehan
Province
Isfehan
Postal code
81551-39998
Phone
+98 936 668 9455
Email
mhs.ahmadishadmehri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
vahid esfahanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
islamic azad university of isfahan., arghavanie ave., Jey blv., isfahan.
City
isfehan
Province
Isfehan
Postal code
81558-39998
Phone
+98 31 3500 2141
Email
mhs.ahmadishadmehri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
vahid esfahanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
islamic azad university of isfahan., arghavanie ave., Jey blv., isfahan.
City
isfehan
Province
Isfehan
Postal code
81558-31998
Phone
00983235002141
Email
mhs.ahmadishadmehri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
mahsa ahmadi shadmehri
Position
postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no.59- 5th sadaf street- vakilabad blv
City
mashhad
Province
Razavi Khorasan
Postal code
81558-31998
Phone
+98 51 3867 4195
Email
mhs.ahmadishadmehri@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
data of primary outcomes collected via CBCT or periotest will be shared if necessary.
When the data will become available and for how long
data will be shared 6 months after the publication of the study.
To whom data/document is available
data will be available for academic institutions and researchers who ask for.
Under which criteria data/document could be used
data will be avilable for researchers who need them for similar researches or systematic review and meta-anlysis.
From where data/document is obtainable
researchers can get the data via Email: mhs.ahmadishadmehri@gmail.com
What processes are involved for a request to access data/document
after sending an email for the data request, data will be posted for the researchers within a week.
email: mhs.ahmadishadmehri@gmail.com