Objective: Evaluation of histomorphometric effects of risedronate gel (2%) on reconstruction of calvaria bone defects in New Zealand white rabbit.
Design: Randomized (randomized block design - with two groups of ten, case and control groups); double-blind (blinded for the subjects and evaluation committee); placebo-controlled.
Sample size: Twenty male New Zealand rabbits with the same breed and weight.
Inclusion criteria: Animals with same weight, age and gender; without disease.
Exclusion criteria: Diagnosis of the disease.
Method: Randomized clinical trial.
Duration: Four & eight weeks.
Setting and conduct: After giving anesthesia, we make two full thickness 8 millimeter defects in calvaria bones of each rabbit by using a Dask bur. In group 1, the right defect is filled with risedronate 2% gel and the left defect is empty. In group 2, right defect is filled with placebo gel and left defect remain empty. Then the area will be stitched.
At the end of each month (for two consecutive months - month1 and month2) five rabbits will be euthanized and their calvaria bone will be removed for histomorphometric study, and samples will be sent to pathologist.
Intervention: 1-Risedronate 2% gel; once, during surgery; localized in bone defect. 2-Placebo gel; once, during surgery; localized in bone defect.
Primary outcome variables: The amount of bone filling; inflammation; osteoblasts; oteoclasts; foreign body reaction.
Secondary outcome variables: Infection; presence of the disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081235636N1
Registration date:2017-08-21, 1396/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Shirin Marzoughi
Name of organization / entity
Islamic Azad University, Dental Tehran Branch
Country
Iran (Islamic Republic of)
Phone
+98 912 500 7698
Email address
shirin.marzoughi@gmail.com
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of histomorphometric effects of risedronate gel (2%) on calvaria bone defects in rabbits
Public title
Evaluation of effect of risedronate on the process of bone formation in rabbit's skull
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Animals with same weight, age and gender; without disease.
Exclusion criteria: Diagnosis of the disease.
Age
From 6 months old to 7 months old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Dental Tehran Branch
Street address
10th Neyestan St., Pasdaran Ave., Tehran, Iran.
City
Tehran
Postal code
19585175
Approval date
2014-06-20, 1393/03/30
Ethics committee reference number
24820
Health conditions studied
1
Description of health condition studied
Bone loss
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
The amount of bone filling
Timepoint
Four weeks after intervention, eight weeks after intervention
Method of measurement
by microscopic observation
2
Description
Inflammation
Timepoint
Four weeks after intervention, eight weeks after intervention
Method of measurement
by microscopic observation
3
Description
Osteoblasts
Timepoint
Four weeks after intervention, eight weeks after intervention
Method of measurement
by microscopic observation
4
Description
Osteoclasts
Timepoint
Four weeks after intervention, eight weeks after intervention
Method of measurement
by microscopic observation
5
Description
Foreign body reaction
Timepoint
Four weeks after intervention, eight weeks after intervention
Method of measurement
by microscopic observation
Secondary outcomes
1
Description
Infection
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
Observation, examination
2
Description
The presence of the disease
Timepoint
Before intervention, during intervention
Method of measurement
By the veterinarian
Intervention groups
1
Description
Risedronate 2% gel; once, during surgery; localized in bone defect.
Category
Treatment - Drugs
2
Description
Placebo gel; once, during surgery; localized in bone defect.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Dental Tehran Branch
Full name of responsible person
Dr. Shirin Marzoughi
Street address
10th Neyestan St., Pasdaran Ave., Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Islamic Azad University, Dental Tehran Branch
Full name of responsible person
Dr. Arash Azizi
Street address
10th Neyestan St. , Pasdaran Ave. , Tehran, Iran.
City
Tehran
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 Islamic Azad University, Dental Tehran Branch
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
Islamic Azad University, Dental Tehran Branch
Full name of responsible person
Dr. Shirin Marzoughi
Position
Dentist
Other areas of specialty/work
Street address
10th Neyestan St. , Pasdaran Ave. , Tehran, Iran.
City
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Fax
Email
shirin.marzoughi@gmail.com
Web page address
http://dentaliau.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Dental Tehran Branch
Full name of responsible person
Dr. Shirin Marzoughi
Position
Dentist
Other areas of specialty/work
Street address
10th Neyestan St. , Pasdaran Ave. , Tehran, Iran.
City
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Fax
Email
shirin.marzoughi@gmail.com
Web page address
http://dentaliau.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Dental Tehran Branch
Full name of responsible person
ِِDr. Shirin Marzoughi
Position
Dentist
Other areas of specialty/work
Street address
10th Neyestan St. , Pasdaran Ave. , Tehran, Iran.
City
Tehran
Postal code
19585175
Phone
+98 21 2276 3459
Fax
+98 22763459
Email
shirin.marzoughi@gmail.com
Web page address
http://dentaliau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)