Protocol summary

Summary
Alveolar ridge atrophy is one of the undesirable outcomes of tooth loss which cause some functional and esthetic problems. The clinician should use ridge reconstruction and bone augmentation prior to implant placement. Preservation of alveolar bone after tooth extraction minimize bone resorption and as technique implies preservation of the alveolar architecture and prevention of hard and soft-tissue collapse that minimize or eliminate the necessity for future augmentation procedures. this has been long studied but is still an unresolved problem. In this study we compare the success of edentulous ridge preservation with allograft bone material with or without platelet rich plasma. This study will include 16 mandibular dental sockets of patients referred to period ontology and implant logy department of dental faculty regardless of age and gender. The patients are selected according to inclusion and exclusion criteria (smoking, pregnancy,…) and divide in two groups test and control. In this study we use Decalcified freeze dried Bone Allergenic graft(DFDBA) with platelet rich plasma from patient and resorbable collagen membrane for test group and Decalcified freeze dried Bone Allergenic graft and resorbable collagen membrane for Control group. Variables like: The degree of inflammation, The thickness of bone trabeculae, Bone–Biomaterial contact, The rate of bone formation, Number of vessels, The remaining biomaterials, clinical changes of Buccolingual and Epicoronal width of the ridge are assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309231760N25
Registration date: 2013-10-27, 1392/08/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-10-27, 1392/08/05
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
2013-07-06, 1392/04/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical , histological and histomorphometrical comparison of the effect of decalcified friezed – dried bone allogenic graft with platelet rich plasma for alveolar ridge preservation post extraction.
Public title
The clinical , histological and histomorphometrical comparison of the effect of decalcified friezed – dried bone allogenic graft with platelet rich plasma for alveolar ridge preservation post extraction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: do not be restored with tooth in the lower jaw implants and requires applicants who have indicated remove Ridge preservation; they are healthy; available for follow up courses. Exclusion criteria: patients those who can not go under surgery; cigarette (for now); osteoden - dental infection, untreated gingivitis or periodontist active; patients with teeth ankylosed; overall sense of teeth; patients with diseases that affect the tissue repair; use denture after surgery.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
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
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Approval date
2013-07-02, 1392/04/11
Ethics committee reference number
2726

Health conditions studied

1

Description of health condition studied
Atrophy of the alveolar ridge of the jaws
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge

Primary outcomes

1

Description
Protection statement edentulous
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Clinical

Secondary outcomes

1

Description
The thickness of bone trabeculae
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
View software measure SIS LS Starter

2

Description
The degree of inflammation
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Counting the number of inflammatory cells in high power field

3

Description
Bone - Biomaterial
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Observed in high power field microscopy

4

Description
The rate of bone formation
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Calculating the area occupied by bone SIS LS Starter Software

5

Description
Number of vessels
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Counting the number of vessels

6

Description
The remaining biomaterials
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
Calculating the area occupied by bone SIS LS Starter Software

7

Description
Clinical changes buccolingual ridge width
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
clinical

8

Description
Clinical changes Epicocoronal ridge
Timepoint
2 weeks after suture and 3 months after implant insertion time
Method of measurement
clinical

Intervention groups

1

Description
Intervention group: Decalcified freeze dried Bone Allergenic graft(DFDBA) 0.5cc made in Iranian tissue bank with platelet rich plasma from patient and resorbable collagen membrane
Category
Treatment - Drugs

2

Description
Control group: Decalcified freeze dried Bone Allogenicgraft(DFDBA) 0.5cc and resorbable collagen membrane(15.20mm)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental colleges of Babol
Full name of responsible person
Dr. I San Pouri
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
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, Ganjafroz 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. I-San Pouri
Position
Post graduate student of periodontology
Other areas of specialty/work
Street address
Dental School, Babol - Babol University of Medical Sciences- Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
Isanpouri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental School, Babol- Babol University of Medical Sciences
Full name of responsible person
Dr. Niloofar Jenabiyan
Position
Periodontology
Other areas of specialty/work
Street address
Dental School, Babol - Babol University of Medical Sciences- Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1093
Fax
Email
n.jenabian@mubabol.ac.ir
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
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
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
Loading...