Background & Aim:
CenoBone is an allograft-derivated bone bio-implant with different advantages including simple handling and lack of infectious and immune responses. Furthermore, resorption and edentoulus alveolar ridge atrophy is associated with implant treatments requiring alveolar ridge augmentations. CenoBone biomaterial can be effective to induce bone formation or repair bone lesions having positive results in the augmentation of edentoulus ridge for dental implants. The present study will measure clinical, histologic and histomorphometric indices of Bone Strip Allograft with absorbable membrane in the reconstruction horizontal alveolar ridge.
Materials & Methods:
After local anesthesia, a crestal incision will be made using bistury blade No: 15.0 in the edentoulus ridge of patients following two vertical incisions in the ends of horizontal incision. Full-thickness flap will be raised up to access ridge buccal bone while all soft tissues will be removed. Ridge buccolingual thickness will be measured and validated by 3D bone caliper on the 2, 4 and 10mm distances from the bone crest clinically.
Bone strip will be fixed on the bone by 2 screws and hollow strip areas will be filled with demineralized cortical cancellous powder. Cenomembrane membrane will be placed on the graft material. Flap will be placed on the membrane and will be sutured. Five months later and prior to Re-entry; new calculations of ridge buccolingual width on the soft tissue will be made. The specimens will be sent for histologic and histomorphometric assessment.
Biopsies will be imaged and the bone formed areas will be assessed regarding percent of bone formations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202251760N16
Registration date:2012-04-28, 1391/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-28, 1391/02/09
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical, Histologic and histomorphometric evaluation of Bone Strip Allograft with resorb able membrane in horizontal alveolar ridge augmentation
Public title
Clinical, Histologic and histomorphometric evaluation of Bone Strip Allograft with resorb able membrane in horizontal alveolar ridge augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 to 60 years old; Requiring augmentation and implant restorations; Adequate bone height; Inadequate buccolingual thickness and width (ridge thickness having widths less than 5mm with minimum 2mm measured clinically on the soft tissue).
Exclusion criteria: involvement of systemic conditions like uncontrolled diabetes, drug addiction, pregnancy, uncooperative patients and active untreated periodontal disease.
Age
From 20 years old to 60 years old
Gender
Both
Phase
4
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
The ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2012-02-07, 1390/11/18
Ethics committee reference number
5720
Health conditions studied
1
Description of health condition studied
horizontal alveolar ridge augmentation
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
horizontal alveolar ridge augmentation
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
Secondary outcomes
1
Description
The inflammation
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
2
Description
Presence or absence of foreign body reaction
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
3
Description
Properties of bone-biomaterial contact
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
4
Description
Thickness of bone trabeculae
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
5
Description
Bone Vitality
Timepoint
5 months after putting the bones
Method of measurement
Laboratory
Intervention groups
1
Description
Usage of CenoBone;
an allograft-derivated bone bio-implant that has many treatment advantages.
(Manufacturer: Kish replicating tissue)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Babol
Full name of responsible person
Dr. Amir Kiakojori
Street address
Dental School, Babol University of Medical Sciences, Ganjafruz Road
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz 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 and Technology, 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
Dental School, Babol
Full name of responsible person
Dr. Amir Kiakojori
Position
Post graduate student of periodontology
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
Email
stocktray_a2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Babol University of Medical Sciences
Full name of responsible person
Dr. Babak Amoian
Position
Periodontologist
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
Fax
Email
amoian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani steert
City
Babol
Postal code
Phone
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)