Comparison of histological and radiological effect of FDBA with and without autogenous bone graft with collagen membrane in horizontal augmentation of alveolar bone in patients referred to Kerman dental school
Aim of the study: histological and radiological comparison of FDBA with and without autogenous bone graft and collagen membrane for horizontal augmentation of alveolar bone.
Design: randomized controlled clinical trials.
The study populations: patients of Kerman university of medical sciences.
Inclusion criteria: need to horizontal augmentation of alvolar bone for implant (edentulous ridge width: 2/5 - 4 mm and in B-W group)
Exclusion criteria: contraindications for implant treatment (use of more than 10 cigarettes per day pregnancy; non controlled periodontal diseases; use of bisphosphonate and corticosteroid; chemotherapy and radiotherapy; systematic diseases for example: non controlled diabetes; osteoporosis and immune deficiency)
sample size: 20
Intervention: use of FDBA with and without autogenous bone graft.
time of intervention: 6 months befor insert the implant.
outcome: horizontal graft of alveolar bone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109165305N3
Registration date:2017-06-25, 1396/04/04
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9021
Email address
m_mohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman dental and oral diseases research, vice chancellor for research, Kerman university of medical sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of histological and radiological effect of FDBA with and without autogenous bone graft with collagen membrane in horizontal augmentation of alveolar bone in patients referred to Kerman dental school
Public title
Comparison of tow different bone grafts for horizontal graft of alveolar bone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: need to horizontal augmentation of alvolar bone for implant (edentulous ridge width: 2/5 - 4 mm and in B-W group)
Exclusion criteria: contraindications for implant treatment (use of more than 10 cigarettes per day; pregnancy; non controlled periodontal diseases; use of bisphosphonate and corticosteroid; chemotherapy and radiotherapy; systematic diseases for example: non controlled diabetes; osteoporosis and immune deficiency)
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
controlled clinical trials
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of kerman medical sciences university
Street address
Tahmasebabad crossroads, researches center
City
Kerman
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.KMU.REC.1396.1098
Health conditions studied
1
Description of health condition studied
Bone loss
ICD-10 code
M85.8
ICD-10 code description
Other specified disorders of bone density and structure
Primary outcomes
1
Description
Horizontal dimension of alveolar ridge
Timepoint
6 month after insert the implants
Method of measurement
By CBCT
Secondary outcomes
1
Description
Histology of new formed bone
Timepoint
6 months after insert the implants
Method of measurement
Observation with optical microscope
Intervention groups
1
Description
Intervention: Bone graft surgery of alveolar ridge with freezed dried bone allograft {1000-2000 microns granules (Kish tissue regeneration, Kish, Iran) and autogenous bone graft from ramus or chin of patient' own, with 1:1 proportion.
Category
Treatment - Surgery
2
Description
Control: Bone graft surgery of alveolar ridge with freezed dried bone allograft {1000-2000 microns granules (Kish tissue regeneration, Kish, Iran) alone.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Dept.,kerman Dental School
Full name of responsible person
Dr. Mohammad Mohammadi
Street address
Shafa street, Dental school
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman University of Medical Science
Full name of responsible person
Dr. Shahravan
Street address
Tahmasbabad Crossroads
City
kerman
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, Kerman University of Medical Science
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
Periodontics Department, kerman dental school
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Assistant professor/Periodontology
Other areas of specialty/work
Street address
Shafa street, Dental School
City
kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
Email
mmohammadi28@yahoo.com;m_mohammadi@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman dental school
Full name of responsible person
Dr.Mohammad Mohammadi
Position
Assistant professor/periodontology
Other areas of specialty/work
Street address
Shafa street
City
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
Email
mmohammadi28@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman dental school
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Assistant professor/periodontology
Other areas of specialty/work
Street address
Shafa street
City
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
Email
mmohammadi28@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)