evaluation of different particle size bone material in preserving if dental socket
Design
clinical trial,randomized,blind, without control group,25 patient input
Settings and conduct
dentistry factuly of Ahwaz joundishapour university of medical science.
using similar package of bone material
Participants/Inclusion and exclusion criteria
hopless teeth,healthy systemically.endodontic reason or caries that can't restore.patient who want to placing dental implant
Intervention groups
tooth extractin and filing the socket with bone material small particle size in first group and large particle size in second group.then bone material coverd by collagen membrane and flap sutured
Main outcome variables
increasing or preserving height and width of alveolar bone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191015045118N1
Registration date:2019-12-04, 1398/09/13
Registration timing:retrospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Seyed alireza Moosavi azarang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 4141
Email address
dr.alirezamoosavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
2017-11-01, 1396/08/10
Actual recruitment end date
2019-01-30, 1397/11/10
Trial completion date
2019-04-30, 1398/02/10
Scientific title
Evaluation of different particle size of Iranian allograft(cenobone) in socket preservation procedure
Public title
Socket preservation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient that have Hopless tooth
Systemically healthy
First, a list was made and patients were added to the list at the time of referral. Patients were randomly divided into two groups by random number table. In the first group, small particle size was used for socket preservation and in the second group, large particle size was used
Blinding (investigator's opinion)
Single blinded
Blinding description
Using unknown particle size that patient don't knows how many particle size used(using similar package)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
9414974877
Approval date
2018-08-29, 1397/06/07
Ethics committee reference number
Ir.ajums.rec.1397.338
Health conditions studied
1
Description of health condition studied
Socket preservation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Height and width of alveolar ridge
Timepoint
first day and after 4 month
Method of measurement
using CBCT(cone beam cumputered tomography) measurement tools to evaluate ridge dimention
Secondary outcomes
1
Description
no need to any secendry bone augmentation
Timepoint
first day and 4 month
Method of measurement
CBCT measerment tools
Intervention groups
1
Description
first group, small particles sized bone graft material was used and The same collagen membrane was applied to the bone powder. The gingiva was finally sutured and the sutures were removed after two weeks.
Category
Treatment - Surgery
2
Description
Intervention group: second group, the large particle size was used. The same collagen membrane was applied to the bone powder for both groups. The gingiva was finally sutured and the sutures were removed after two weeks.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental factuly of Ahwaz university of medical science
Full name of responsible person
Seyed alireza moosavi azarang
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
9414974877
Phone
+98 61 3336 2414
Email
dr.alirezamoosavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badvi
Street address
golestan
City
Ahwaz
Province
Khouzestan
Postal code
9414974877
Phone
+98 61 3336 2414
Email
dr.alirezamoosavi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed alireza moosavi azarang
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
9414974877
Phone
+98 61 3336 2414
Email
Dr.alirezamoosavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
leila golpasand hagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
golestan
City
ahwaz
Province
Khouzestan
Postal code
9414974877
Phone
+98 61 3336 2414
Email
dr.alirezamoosavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
leila golpasand hagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
golestan
City
ahwaz
Province
Khouzestan
Postal code
9414974877
Phone
+98 61 3336 2414
Email
dr.alirezamoosavi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcom will share
When the data will become available and for how long
We start to share after june 2020
To whom data/document is available
Any one can access to data
Under which criteria data/document could be used
Any one can use
From where data/document is obtainable
Dentistry factuly of ahwaz jundishapour univercity
What processes are involved for a request to access data/document