Protocol summary

Summary
Title: A histologic, histomorphometric and radiographic comparison between two complex of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral ridge augmentation: a preliminary study. Objectives: The aim of this study is to compare Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral alveolar bone augmentation. Design: This single blind randomized clinical trial is conducted on eight sites which require lateral bone augmentation. Setting and conduct: Samples are selected from subjects seeking implant replacement within the age range of 30 to 50 years and require bone augmentation who present department of periodontology and implant, Faculty of dentistry, Babol University of Medical sciences. The minimum required sample size is evaluated to be 8 for conducting semi experimental clinical trial. Major Inclusion and Exclusion criteria: Samples with alveolar bone width of 2 to 4 mm at distance of 3 mm from the crest are included in the study. Patients with certain systemic conditions which affect healing process, patients with poor compliance, sufferers from active periodontal diseases and subjects who don't want to participate in the study are excluded. Intervention: Patients matching is performed with regard to gender, age, general health, and smoking state of subjects. Patients are assigned to either of two experimental groups. Surgical process is conducted using either of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in each group. Main outcome measures: six months later at reentry surgery, core biopsies are taken and trabecular thickness, percentage of osseous formation, extent of inflammation, foreign body reaction, vitality, biomaterial/bone contact, and number of blood vessels are evaluated by means of histologic and histomorphometric observations. The radiographic width of alveolar ridge at initial and reentry surgeries is measured using CBCT.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031621494N1
Registration date: 2015-07-17, 1394/04/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Seyed Mohammad Ali Tabatabaei
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1408
Email address
ma.tabatabaei@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences, Vice chancellor for research and technology
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A histologic, histomorphometric and radiographic comparison between two complex of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral ridge augmentation: a preliminary study.
Public title
A histologic, histomorphometric and radiographic comparison between two complex of Cenobone/ Cenomembrane and Bio Oss/ Bio Gide in lateral ridge augmentation: a preliminary study.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Subjects within the age range of 30 to 50 years, and with sufficient alveolar bone height who have alveolar ridge width of 2 to 4 mm in the area at a distance of 3 mm from the ridge crest are included in the study. Exclusion criteria: Patients with certain systemic conditions which affect healing process are excluded from the survey, including: Uncontrolled diabetes; immune disorders; alcohol addiction; drug abuse; current smoking; pregnancy; immune suppressor or anticoagulant drugs consumption. Additionally, patients with poor compliance; sufferers from active periodontal diseases which complicate oral hygiene; and subjects who don't want to participate in the study are excluded.
Age
From 30 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ethics committee, Babol University of Medical Sciences, Ganj Afrooz St., Babol.
City
Babol
Postal code
47176- 47745
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
5121

Health conditions studied

1

Description of health condition studied
Lateral alveolar ridge augmentation
ICD-10 code
k08.2
ICD-10 code description
Atrophy of edentulous ridge

Primary outcomes

1

Description
Lateral ridge augmentation
Timepoint
Six months following grafting
Method of measurement
Radiographic, histologic, and histomorphometric measures

Secondary outcomes

1

Description
Trabecular thickness
Timepoint
Six months following grafting
Method of measurement
Histomorphometric evaluation six months following grafting

2

Description
Number of blood vessels
Timepoint
Six months following grafting
Method of measurement
Evaluation in microscopic fields, six months following grafting

3

Description
Extent of inflammation
Timepoint
Six months following grafting
Method of measurement
Evaluation in microscopic fields, six months following grafting

4

Description
Foreign body reaction
Timepoint
Six months following grafting
Method of measurement
Evaluation in microscopic fields, six months following grafting

5

Description
Bone vitality
Timepoint
Six months following grafting
Method of measurement
Evaluation in microscopic fields, six months following grafting

6

Description
Biomaterial/bone contact
Timepoint
Six months following grafting
Method of measurement
Evaluation in microscopic fields, six months following grafting

7

Description
Biomaterial/bone radiographic density
Timepoint
Six months following grafting
Method of measurement
CBCT examination, six months following grafting

8

Description
Percentage of biomaterial remnants
Timepoint
Six months following grafting
Method of measurement
Histomorphometric evaluation six months following grafting

Intervention groups

1

Description
Intervention group: Cenobone/ Cenomembrane. In this group, Cenobone granules with size of 150 to 1000 microns (Mineralized Cortico Cancellous powder) which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Cenomembrane with thickness of 0.2 to 0.6 microns which originates from allogenic pericardium, is placed over the graft materials. Both bone powder and absorbable membrane are products of Hamanandsaz Baft Kish, Iran.
Category
Treatment - Surgery

2

Description
Intervention group:Bio Oss/ Bio Gide. In this group, Bio Oss granules with size of 500 to 1000 microns which have been immersed in normal saline for 30 minutes, are placed in the defected area of bone in such a manner that provide sufficient bone thickness for implant placement in buccal and lingual sides of the ridge. Consequently, absorbable Bio Gide membrane with standard thickness which originates from pig collagen, is placed over the graft materials. Both bone powder and absorbable membrane are products of Geistlich Biomaterials (Bio Oss, Geistlich Pharma AG, Wolhusen, Switzerland).
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Ali Tabatabaei
Street address
Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol.
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Babol University of Medical Sciences
Full name of responsible person
Dr Ali Akbar Moghadamnia
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganj Afrooz St., Babol
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 of 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
Dr Seyed Mohammad Ali Tabatabaei
Position
Postgraduate student of periodontics
Other areas of specialty/work
Street address
Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol
City
Babol
Postal code
47176- 47745
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
ma.tabatabaei@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 Babak Amoeian
Position
Associate professor of periodontics
Other areas of specialty/work
Street address
Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol
City
Babol
Postal code
47176- 47745
Phone
+98 11 3219 9592
Fax
+98 11 3229 1093
Email
amoian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Dentistry,Babol University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Ali Tabatabaei
Position
Postgraduate student of periodontics
Other areas of specialty/work
Street address
Department of periodontology, Faculty of Dentistry, Babol University of Medical Sciences, Ganj Afrooz St., Babol
City
Babol
Postal code
47176- 47745
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
ma.tabatabaei@mubabol.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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