With this study, it is aimed to determine which of the xenografts: Bio-Oss and BonePlus+C, are more successful in socket preservation after extraction.
Design
randomized clinical trial with control group, parallel group, double blinded
Settings and conduct
This split mouth designed randomized clinical trial is conducted on patients in need of at least two extractions in the same jaw. Patients refer to the Oral and Maxillofacial department of dental branch of Islamic Azad University of Tehran, and have the indication of delayed implant placement. Extractions
are done by a surgeon and dental sockets are randomly divided into control (Bio-Oss) and examine (BonePlus+C) groups. sockets are filled with these bio materials. After four months, patients are recalled and healing is assessed via biopsy of the grafted sites and histomorphometric analysis.
Participants/Inclusion and exclusion criteria
Patients in need of at least two extractions in the same jaw with the indication of delayed implant placement. Patients have a good overall health and the exclusion criteria is as followed: systemic and metabolic diseases, periapical lesion, acute infection at the site of surgery, smoking more than 10 cigarettes per day.
Intervention groups
In order to improve the healing of bone defects after extraction, alveplae sockets of each patient are randomly divided into control (Bio-Oss) and examine (BonePlus+C) groups; and the sockets are filled with these bio-materials.
Main outcome variables
number of pixels of newly formed bone; number of pixels of remained bio-material
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180619040159N1
Registration date:2018-07-07, 1397/04/16
Registration timing:registered_while_recruiting
Last update:2018-07-07, 1397/04/16
Update count:0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Farnaz Keyhanlou
Name of organization / entity
Tehran Dental Branch of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 4855
Email address
f_sarkarat@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of BonePlus+C and Bio-Oss in socket preservation after extraction
Public title
BonePlus+C in socket preservation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a good overall health in need of at least two extractions in the same jaw with the indication of delayed implant placement
Exclusion criteria:
Patients with systemic or metabolic diseases
Existing periapical lesion
Presence of acute infection at the site of surgery
Smoking more than ten cigarettes per day
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
5
More than 1 sample in each individual
Number of samples in each individual:
2
Alveolar socket after extraction
Randomization (investigator's opinion)
Randomized
Randomization description
The extraction sockets in each patient were randomly divided into control and examine groups by Excel software. Date were given to the function of "Random" in this software, and the output contained the information on the type of material that should be placed in each extraction socket.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blind towards the control and examine groups applied to their sockets. They are not aware of the type of material that is placed in each extraction socket. In addition, pathologist of the study is also blind towards the type of samples. The samples sent to the pathologist only contain a given number, and no further information about the type of material or the patient; and only the surgeon is aware of this information.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dental branch of Islamic Azad University of Tehran
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1397,1
Health conditions studied
1
Description of health condition studied
Bony defects of alveolar socket after extraction
ICD-10 code
M84.8
ICD-10 code description
Other disorders of continuity of bone
Primary outcomes
1
Description
number of pixels of newly formed bone
Timepoint
4 months after the first surgery
Method of measurement
Histomorphometric analysis
2
Description
number of pixels of remained bio-material
Timepoint
4 months after the first surgery
Method of measurement
Histomorphometric analysis
Secondary outcomes
empty
Intervention groups
1
Description
Control group: placement of Bio-Oss bio-material in the extraction socket
Category
Treatment - Other
2
Description
Intervention group: placement of BonePlus+C bio-material in the extraction socket
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
بخش جراحی دهان و فک و صورت دانشگاه آزاد اسلامی تهران
Full name of responsible person
فرزین سرکارات
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2258 0933
Email
f_sarkarat@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Branch of Islamic Azad Universitu of Tehran
Full name of responsible person
Farzin Sarkarat
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2258 0933
Email
f_sarkarat@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Branch of Islamic Azad Universitu of Tehran
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
Dental Branch of Islamic Azad University of Tehran
Full name of responsible person
Farzin Sarkarat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2258 0933
Email
f_sarkarat@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Branch of Islamic Azad University of Tehran
Full name of responsible person
Farzin Sarkarat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2258 0933
Email
f_sarkarat@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental Branch of Islamic Azad University of Tehran
Full name of responsible person
Farnaz Keyhanlou
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2258 0933
Email
farnazz.kay@gmail.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
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