Alveolar ridge atrophy of the jaw's, which is a basic problem encountered in patients seeking implant treatments, makes the augmentation procedure necessary. Disadvantages of using autografts, such as discomfort due to second stage surgery for harvesting bone from donor site, and limited volume of bone (from intra oral source), have led to interesting focus on using bone substitute materials. Among these materials, Natix made of commercially pure titanium, which is resistant against resorption and has good clotting properties as an osteoconductivee material, has been newly introduced to the market. Therefore the purpose of this study is the histologic and histomorphometric assessment of this biomaterial in horizontal augmentation of resorbed alveolar ridge. The main inclusion criteria: 1- Patients ranging from 30 to 50 years old 2- Healthy patients demanding implant treatment in posterior regions of mandibular alveolar ridge The main exclusion criteria: 1- Patients unable to maintain oral health status or not interested in maintaining oral health status 2- Patients having untreated active periodontal disease. Target sample size: Comprises 10 augmentation sites in patients having a minimum of one augmentation site Time for intervention in order to assess the material from a histologic and histomorphometric standpoint is 8 month after augmentation. The primary outcome measure is the assessment of Natix for horizontal augmentation of alveolar ridge in terms of histologic and histomorphometric analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903164106N1
Registration date:2010-10-26, 1389/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-26, 1389/08/04
Registrant information
Name
Javad Mehrani Sabet
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2246 7316
Email address
j.mehrani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2010-03-06, 1388/12/15
Expected recruitment end date
2011-01-05, 1389/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histologic and Histomorphometric Evaluation of Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation
Public title
Histologic and Histomorphometric Evaluation of Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients ranging from 30 to 50 years old 2- Patients demanding implant treatment in posterior regions of mandibular alveolar ridge 3- Sufficient vertical height of bone in posterior mandibular region with inadequate buccolingual width (width of less than 5 mm and minimum width of 2 mm) 4- Healthy patients 5- Minimum of one augmentation site for each patient requiring implant treatment. Exclusion criteria: 1- Patients having systemic conditions affecting healing such as: Uncontrolled Diabetes, Immune diseases, Systemic or local diseases of bone, history of Alcoholism, Patients taking Immunosuppressive or Anticoagulant medications 2- poor compliance 3- Patients having untreated active periodontal disease 4- Patients unable to maintain oral health status or not interested in maintaining oral health status.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Periodontic Department, Faculty of Dentistry, Medical University, Ganjafrooz Avenue
City
Babol
Postal code
4717647745
Approval date
empty
Ethics committee reference number
30.166.ژ.پ
Health conditions studied
1
Description of health condition studied
Histologic and histomorphometric analysis of horizontal alveolar ridge augmentation
ICD-10 code
K08
ICD-10 code description
Other disorders of teeth and supporting structures
Primary outcomes
1
Description
Histologic and Histomorphometric Evaluation of effect of Natix Synthetic Biomaterial in Horizontal Alveolar Ridge Augmentation
Timepoint
8 months after intervention
Method of measurement
Biopsy specimens are taken from the augmented site by Natix, and are stained with Hematoxilin & Eosin and parameters such as: 1-amount of inflammation 2-existence or inexistence of foreign body reaction (giant cells and granulomatous reactions) 3-Bone vitality (Existence or inexistence of osteocytes in lacunaes) 4-Thickness of bone trabecules 5-Way of contact between bone-biomaterial (existence or inexistence of connective tissue between bone fragments) are analysed
Secondary outcomes
empty
Intervention groups
1
Description
After reflection of a full-thickness flap for gaining access to the buccal bone of edentulous ridge, Natix biomaterial is mixed with blood and saline and then placed on the area of bone defect. Then the augmneted area will be covered by Cytoplast resorbable membrane. Without any tension the flaps are tied together. 8 month after surgery, full thickness flaps are reflected for the purpose of implant surgery. Biopsy specimens in shape of a bone core are harvested from the area of implant insertion. Specimens are sended to laboratory for histologic and histomorphometric study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Dr Javad Mehrani Sabet
Street address
Periodontic Department, Faculty of Dentistry, Medical University, Ganjafrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Dr Amrollah Mostafazadeh
Street address
Depatment of Periodontics, Faculty of dentistry, Medical Uneversity, Ganjafrooz avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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, Faculty of Dentistry
Full name of responsible person
Dr Javad Mehrani Sabet
Position
Post Graduate Student
Other areas of specialty/work
Street address
Depatment of Periodontics, Faculty of dentistry, Medical Uneversity, Ganjafrooz avenue
City
Babol
Postal code
Phone
+98 11 1222 4032
Fax
Email
j.mehrani@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
Dr Javad Mehrani Sabet
Position
Post Graduate Student
Other areas of specialty/work
Street address
Depatment of Periodontics, Faculty of dentistry, Medical Uneversity, Ganjafrooz avenue
City
Babol
Postal code
Phone
+98 11 1222 4032
Fax
Email
j.mehrani@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
Dr Javad Mehrani Sabet
Position
Post Graduate Student
Other areas of specialty/work
Street address
Depatment of Periodontics, Faculty of dentistry, Medical Uneversity, Ganjafrooz avenue
City
Babol
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)