A randomized clinical trail on effectiveness of Plasma Rich in Growth Factors (PRGF) in combination with iliac autogenous bone graft versus PRGF with Demineralized Bone Matrix ( DBM) in repairing of alveolar clefts
The standard method for alveolar cleft treatment is bone grafting from iliac bone. However, osseointegration may not occur in some. Efforts have been made to improve the surgery results by using several plasma factors such as PRP, PRGF, BMP-2, etc. There are also studies reporting successful results using allografts with or without growth factors. The main objective of this study is to compare the application of autogenous iliac bone grafting with PRGF versus DBM with PRGF in unilateral cleft bone treatment. The study population included unilateral lip and palate and alveolar cleft patients. They were categoraized into secondary and tertiary grafts groups according to their dental development. The patients in the secondary or tertiary graft categories were randomly assigned into the two intervention groups: grafting with iliac +PRGF (n=16) and grafting with DBM+PRGF (n=16). The outcome will be measured six month later as the proportion of the remaining bone to the pre-surgery cleft volume.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801161790N1
Registration date:2010-12-04, 1389/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-04, 1389/09/13
Registrant information
Name
Gholamreza Shirani
Name of organization / entity
Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2131
Email address
shirani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center, dental school, Tehran university of medical sciences
Expected recruitment start date
2008-05-04, 1387/02/15
Expected recruitment end date
2009-09-21, 1388/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trail on effectiveness of Plasma Rich in Growth Factors (PRGF) in combination with iliac autogenous bone graft versus PRGF with Demineralized Bone Matrix ( DBM) in repairing of alveolar clefts
Public title
A randomized clinical trail on effectiveness of Plasma Rich in Growth Factors (PRGF) in combination with iliac autogenous bone graft versus PRGF with Demineralized Bone Matrix ( DBM) in repairing of alveolar clefts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Presence of unilateral alveolar cleft in lip and palate cleft patients, 2) The age range of 8 to 30 years, Exclusion criteria: 1) Systemic disease or congenital syndrome 2) Patients who have previously had the same operation
Age
From 8 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Ghods St., crossing with Keshavarz St.,
City
Tehran
Postal code
Approval date
2009-08-04, 1388/05/13
Ethics committee reference number
88-02-69-7155
Health conditions studied
1
Description of health condition studied
Repair of alveolar cleft in lip and palatal cleft patients
ICD-10 code
Q37.5
ICD-10 code description
Cleft hard and soft palate with unilateral cleft lip
Primary outcomes
1
Description
Formation of bony bridge in alveolar cleft
Timepoint
6 month
Method of measurement
Measuring of bony bridge volume in alveolar cleft in ct scan
Secondary outcomes
1
Description
Determining volume of bone formation
Timepoint
6 month
Method of measurement
measuring of volume of grafted bone by ct scan
Intervention groups
1
Description
Application of DBM in combination with PRGF in Alveolar cleft grafting (Intervention group)
Category
Treatment - Other
2
Description
Application of autogenous Illiac crest bone in combination with PRGF in Alveolar cleft grafting (control group)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial Surgery Clinic of Shariati Hospital
Full name of responsible person
Dr Amir Jalal Abbasi
Street address
Maxillofacial Surgery Clinic of Shariati Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Elaheh Alamdar
Street address
Ghods St., crossing with Keshavarz St.,
City
Tehran
Grant name
Grant code / Reference number
88-02-69-7155
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Dr Amir Jalal Abbasi
Position
Resident of maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial Surgery Ward , Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2131
Fax
Email
jabbasi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Shirani
Position
Maxillofacial Surgeon
Other areas of specialty/work
Street address
Maxillofacial Surgery Ward , Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2131
Fax
Email
shirani @sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Tehran University of Medical Sciences
Full name of responsible person
Dr Amir Jalal Abbasi
Position
Resident of maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial Surgery Ward , Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2131
Fax
Email
jabbasi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)