The purpose of this study is assessing the effect of two methods of bone harvesting during implant preparation surgery on cell viability of graft. Inclusion criteria include having no systemic disease and progressive periodontal disease and having good oral hygiene. Exclusion criteria include smoking, pregnancy, history of radiotherapy/chemotherapy and having bone anomalies. 90 patients, that refer to periodontology department of Dentistry Faculty of Hamadan University of Medical Science for implant insertion surgery in 2015-2016, will be selected for this study. Patients will be divided randomly to two groups of 45 patients. During implant preparation surgery, in the first group, bone particle will be harvested using implant surgery micromotor and in the second group it will be harvested by piezosurgery device. Then cell viability will be assessed by using MTS Cell Proliferation Colorimetric Assay kit and spectrophotometer device in the wavelength of 490 nm.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102624726N1
Registration date:2015-11-18, 1394/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Masume Nikkhah Rankoohi
Name of organization / entity
Hamadan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
Email address
m.nikkhah@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implant preparation with piezoelectric and conventional drilling on auto graft cell viability
Public title
The effect of two method of implant site preparation on graft cell viability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No systemic disease ; No smoking ; No pregnant female ; No periodontal disease ; Appropriate oral hygiene ; No radiotherapy/chemotherapy ; No taking immunosuppressive drugs
Exclusion criteria: Patients with systemic diseases such as diabete mellitus and bone anomalies and diseases and progressive periodontal disease ; Pregnancy ; Smoking ; Unacceptable oral hygiene ; Radiotherapy/chemotherapy ; Taking immunosuppressive drugs and prolonged steroid therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Hamadan University of Medical Science
Street address
In Front of Mardom park- Shahid Fahmide Ave- Hamadan
City
Hamadan
Postal code
654178-38741
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.UMSHA.REC.1394.248
Health conditions studied
1
Description of health condition studied
Implant treatment
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
Maintain of graft cell viability
Timepoint
Immediately after intervention
Method of measurement
Based on cellular titre in percentage
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Harvesting of bone particle by drills of piezosurgery device and analysis of bone cell viability by MTS kit
Control group: Harvesting of bone particle by conventional drills and analysis of bone cell viability by MTS kit
Category
Treatment - Surgery
2
Description
Control group: Bone paticle harvesting during implant preparation using conventional drill and assessing viability of bone cells using MTS kit
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Hamadan University of Medical Science
Full name of responsible person
Masume Nikkhah Rankoohi
Street address
Dentistry Faculty of Hamadan University of Medical Science, in front of Mardom Park, Shahid Fahmide Avenue, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Shahin Kasraii
Street address
Dentistry Faculty of Hamadan University Of Medical Science
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Science
Full name of responsible person
Dr. Masume Nikkhah Rankoohi
Position
post graduate student
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
m.nikkhah@edu.umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr. Janet Moradi Haghgoo
Position
Assistant professor
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
J.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Dr. Masume Nikkhah Rankoohi
Position
Post graduate student
Other areas of specialty/work
Street address
Dentistry Faculty of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)