Comparative histological and radiological results of Nano-crystalline hydroxyapatite (Ostim) and Bio-oss used in maxillary sinus augmentation: a human study
The aim of present study was Comparative histological and radiological results of Nano-crystalline hydroxyapatite (Ostim) and Bio-oss used in maxillary sinus augmentation: a human study
the critical inclusion and exclusion criteria were 1-maxillary partial (unilateral or bilateral) edentulism or complete edentulism 2-Rresidual bone height between the sinus floor and the alveolar crest less than 5 mm. 10 patients (5 patients test group and 5 patients control group) selected randomly and sinus augmentation was performed with Ostim (test group) and Bio-oss ( control group) .Parameters evaluated were percentage of new bone formation,and percentage of residual graft material and residual bone height between the sinus floor and the alveolar crest in baseline and after sinus augmentation. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204157128N2
Registration date:2012-12-10, 1391/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-10, 1391/09/20
Registrant information
Name
Adileh Shirmohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
shirmohamadia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical science
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative histological and radiological results of Nano-crystalline hydroxyapatite (Ostim) and Bio-oss used in maxillary sinus augmentation: a human study
Public title
Comparative histological and radiological results of two bone grafts used in maxillary sinus augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; maxillary partial (unilateral or bilateral) edentulism or complete edentulism; Rresidual bone height between the sinus floor and the alveolar crest less than 5 mm. The exclusion criteria: smokers; pregnant women; maxillary sinus pathology; cystic lesions of the maxillary sinus; systemic disease; e.g unstable diabetes; heart disease; malignancies; radiotherapy for head and neck especially maxilla; autoimmune diseases; metabolic diseases that becomes difficult to the healing of the soft and hard tissue (e.g osteoporosis, hyperparathyroidism ,...); steroids and immunosuppressive drugs; bisphosphonates drug; untreated periodontal disease and periapical disease especially in teeth; which are close to the sinuses.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences- Dentistry faculty
Street address
Golgasht street,daneshgah street,Tabriz, Iran
City
Tabriz
Postal code
Approval date
2012-09-27, 1391/07/06
Ethics committee reference number
91127
Health conditions studied
1
Description of health condition studied
maxillary sinus augmentation due to bone resorbtion
ICD-10 code
M86-M90
ICD-10 code description
Other osteopathies
Primary outcomes
1
Description
new bone formation after sinus augmentation
Timepoint
After 5 month
Method of measurement
Microscope
Secondary outcomes
1
Description
residual bone graft after 5 month
Timepoint
After 5 month
Method of measurement
microscope
2
Description
bone density
Timepoint
After 5 month
Method of measurement
CBCT
Intervention groups
1
Description
control group: use of bio-oss in sinus augmentation
Category
Treatment - Surgery
2
Description
Intervention:use of ostim in sinus augmentation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Tabriz, Periodontics ward
Full name of responsible person
Dr Adileh Shirmohamadi
Street address
Golgasht street, Daneshgah street,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Pourabbas
Street address
Tabriz University of Medical Sciences, Golgasht street, Daneshgah street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nasrin Rahmanpour
Position
Periodontics resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street, Daneshgah street, Tabriz,