This prospective clinical trial is performed on 50 patients referred for insertion of dental implants in posterior areas of the maxilla requiring local bone augmentation. In the control group, autogenous bone will be used for maxillary sinus floor augmentation; while in the intervention group, rhBMP2/ACS will be used as the graft material. If both sides of the maxillary arch require sinus lifting, one side will be augmented by autogenous bone and the other side by rhBMP2/ACS. In all cases a two-staged procedure will be used for sinus lifting and implant placement. The amount and density of newly formed bone will be evaluated by CBCT two, 4, and 6 months after grafting procedure. Furthermore, after 6 months, a biopsy from the implant site will be performed at the time of implant surgery. The specimens will be evaluated by light microscope. After implant placement, patients will be re-examined in terms of implant success and bone resorption every 6 months for a total period of 3 years.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901243703N1
Registration date:2010-03-20, 1388/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-20, 1388/12/29
Registrant information
Name
Majid Beshkar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 7910
Email address
beshkar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of rhBMP-2/ACS as compared to autogenous bone graft in the human maxillary sinus floor augmentation
Public title
Evaluating the effectiveness of rhBMP-2/ACS as compared to autogenous bone graft in the human maxillary sinus floor augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients older than 18 years requiring dental implant in the posterior maxilla Exclusion Criteria: Sinusitis and other sinus pathologies, periodontal disease or active infection in the surgical field, History of unsuccessful sinus lift procedure
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences
Street address
Ghods St., Enghelab St.
City
Tehran
Postal code
Approval date
2010-01-20, 1388/10/30
Ethics committee reference number
1388/12/hgt
Health conditions studied
1
Description of health condition studied
Dental Implant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bone height
Timepoint
Every 2 months
Method of measurement
Radiography
Secondary outcomes
1
Description
Dental implant success
Timepoint
Every one year
Method of measurement
Radiography
Intervention groups
1
Description
Autogenous bone graft harvested from tuberosity during surgery
Category
Treatment - Surgery
2
Description
rhBMP2/ACS which consists of a collagen sponge soaked with a solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Beshkar
Street address
Ghods st, Enghelab st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences and Health Services, Faculty of Dentistry
Full name of responsible person
Majid Beshkar
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Ghods st, Enghelab st,
City
Tehran
Postal code
Phone
+98 21 8338 4232
Fax
Email
majid.beshkar@yahoo.com beshkar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Majid Beshkar
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Ghods st, Enghelab st,
City
Tehran
Postal code
Phone
+98 912 737 1305
Fax
Email
majid.beshkar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Majid Beshkar
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
School of dentistry, Ghods st, Keshavarz Blvd.
City
Tehran
Postal code
Phone
Fax
Email
majid.beshkar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)