The main purpose of this study was to evaluate the inflammatory reaction and amount of new bone formed in the socket ridge after bone grafting.
Design
Double-blind clinical trial will performed on 10 patient with at least one extracted tooth socket. All of the sockets will be filled with Bone+B xenograft biomaterials.
Settings and conduct
This pilot study is performed at shahid beheshti dental school. After recieving informed consent, conservative tooth extraction will be done under local anesthesia. The tooth socket will be filled with the Bone + B biomaterial up to the bone level, covered with collagen sponge and protected with resorbable cross sutures. After 6 months, tissue samples will be taken with trephine bur and dental implants will be inserted.
Participants/Inclusion and exclusion criteria
Age over 18 years
Good general health
Absence of any infection or periapical lesions
Absence of any uncontrolled systemic disease disrupts the healing process (uncontrolled diabetes, ...)
Intervention groups
In this study, Bone + B bone xenograft is used as single biomaterials will be used. there is no control group.
Main outcome variables
degree of tissue inflammation
amount of foreign body reaction
proportion of blood vessels
proportion of newly formed bone and
proportion of graft remnants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201209049656N1
Registration date:2021-02-11, 1399/11/23
Registration timing:registered_while_recruiting
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Reza Amid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 2208
Email address
reza_amid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of histological outcomes of post extraction socket preservation using xenograft bone substitute
Public title
Alveolar ridge preservation with graft material
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
> 18 years old
good systemic health
minimum one tooth irrational to restoration
informed consent
Exclusion criteria:
local infection/ periapical defect
uncontrolled diabetes
smoking
alcohol abuse
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
1
extracted tooth socket
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
a blinded examiner
a blinded statistician
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical sciences
Street address
Shahid Beheshti University of Medical Sciences, Evin, Daneshjoo Blvd., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.SBMU.DRC.REC.1399.054
Health conditions studied
1
Description of health condition studied
Candidate patients to extract teeth and receive implants
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
Histological examinations to determine bone integrity, amount of newly formed bone tissue, amount of biomaterial residue, evaluation of immune stimulation reactions, examination of connective tissue and observation of fibrosis
Timepoint
The amount of bone in the socket is examined 6 months later.
Method of measurement
Histologic evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fresh tooth sockets filled with xenograft biomaterials
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti dental school
Full name of responsible person
Reza Amid
Street address
Shahid beheshti dental school, Daneshjoo Blv, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Fax
+98 21 2242 7753
Email
Amidperio@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice- Chancellor in Research Affairs
Street address
Shahid beheshti university of medical sciences, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
+98 21 2240 3194
Email
info@novateb.com
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
Reza Amid
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshju Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
rezaa_amid@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Amid
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 8802 0238
Email
reza_amid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Amid
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Daneshjoo Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Email
reza_amid@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
6 months after the results are published
From where data/document is obtainable
Dr. Reza Amid, Shahid Beheshti Dental University
What processes are involved for a request to access data/document
Fill in the application form and send it to Shahid Beheshti Dental University