This research is a clinical trial on 6 patients referred to periodontics and dental implant Units of Babol Dentistry College. These patients required dental implants in the posterior maxilla area. The inclusion criteria were patients with general health for whom the implant installation in the posterior maxilla was necessary and had 5mm or less alveolar height. . After a local anesthetia, the horizontal and two vertical incisions were made. After pushing the flap, Window was prepared on the side wall of sinus; and then after placing graft material on sinus bone, the Window surface was covered by a pericardial collagen membrane and stitched.after Six months, implant surgery was performed. On the surgery day, Core biopsy was done after preparing the flap using a Trephine with 3mm diameter and a height of at least 4-5 mm in a space which is supposed to be Implant hole. After demarcation, samples were sent to the pathological laboratory in order to determine the crestal and apical areas. According to the Histomorphometry observations, the thickness of bone trabeculae was determined which had 3 degrees as below:
Grade I: more than 60 microns
Grade II: between 21 to 60 microns
Grade III: between 1 to 20 microns.
At any stage, pathologist was not aware of the content of biopsy.To evaluate the residual bone height, panoramic radiography and CBCT were done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081114323N1
Registration date:2013-09-30, 1392/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-30, 1392/07/08
Registrant information
Name
Hamidreza Safipoor
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1326 9728
Email address
hr.safipor@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2012-09-23, 1391/07/02
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The histological and histomorphometrical evaluation of two grafting materials: cenobone & ITB-MBA in open Sinus Lift Surgery
Public title
The histological and histomorphometrical evaluation of two grafting materials: cenobone & ITB-MBA in open Sinus Lift Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients required dental implants in the posterior maxilla area;bone height between the floor of the sinus and crestal bone was 5mm or less.
Exclusion criteria were:
Uncontrollable Systemic diseases such as diabetes; Acute sinusitis; Chemotherapy during the 12 months before surgery; Radiotherapy more than 5000 rad on the neck and face; Psychological problem
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
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
Babol University of Medical Sciencese
Street address
Ganj Afrooz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
2823
Health conditions studied
1
Description of health condition studied
Biomaterial of Implant surgery
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Bone inflammation
Timepoint
Begin of the studuy, 6th month
Method of measurement
Histologic assessment
Secondary outcomes
empty
Intervention groups
1
Description
Cenobone biomaterial
Category
Treatment - Surgery
2
Description
ITB-MBA biomaterial
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences,Periodontics and implant department
Full name of responsible person
Hamid reza safipoor
Street address
Ganj Afrooz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Manager of Research Office,Amrollah Mostafazadeh
Street address
Ganj Afrooz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hamireza safipoor
Position
Assistant
Other areas of specialty/work
Street address
Ganj Afrooz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
Phone
+98 11 1219 9592
Fax
Email
HR.Safipor@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hamidreza safipor
Position
Assistant
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1219 9592
Fax
Email
HR.Safipor@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hamidreza safipoor
Position
Assistant
Other areas of specialty/work
Street address
Ganj Afrooz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
Phone
00
Fax
Email
HR.safipor@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)