Clinical and radiographic evaluation of chitosan particles in treatment of periodontal intra bony defect
Design
clinical trial - with two test and one control group -double blind - randomized
Settings and conduct
Surgeries are done in periodontology department of Babol dental faculty. Patients don't know that involve in which group. The flap is set to "full thickness" then scaling & root planning is performed. In test groups in three-wall bone lesions, chitosan is placed in low or high molecular weight. Chitosan powder is mixed with some serum and placed in the bone lesion. Then, in each group, place the "Cenomembrane" membrane on the lumbar lesion and suture.
Participants/Inclusion and exclusion criteria
The entry requirements were presence of 3-walled intrabony defects in buccal or lingual sides of upper or lower first or second premolar or molars. The exclusion criteria were suffering from any kind of systemic disorders; a need for prophylactic antibiotics to prevent bacterial endocarditis; taking any drugs interfering with periodontal wound healing; smokers; presence of any periodontal surgery contraindications; teeth with anatomical complications such as cervical enamel projections; bifurcation ridge; accessory canal and concavity; presence of hemiseptal bony defects; presence of caries in the root of teeth adjacent to the intrabony defect and last but not least uncooperative patients
Intervention groups
People are divided into 3 groups. First, the chitosan test was done by the Acros Inc with high molecular weight (MW800000-600000) in intrabony defects during flap. Second, the chitosan test was done by the Acros Inc with low molecular weight (MW300000-100000) and in the control group the flap surgery is only done. The groups are matched with sex and place of the lesions.
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2016-06-30, 1395/04/10
Trial completion date
empty
Scientific title
Clinical and radiographic evaluation of chitosan particles in treatment of periodontal intra bony defect
Public title
the effect of chitosan in periodontal intra bony defect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The entry requirements were presence of 3-walled intrabony defects in buccal or lingual sides of upper or lower first or second premolar or molars.
plaque index under 20
between 30 - 50 years old
Exclusion criteria:
systemic disease
taking any drugs interfering with periodontal wound healing
smokers
presence of any periodontal surgery contraindications
teeth with anatomical complications such as cervical enamel projections; bifurcation ridge; accessory canal and concavity
presence of hemi septal bony defects
presence of caries in the root of teeth adjacent to the intrabony defect
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
18
Actual sample size reached:
18
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization scheme was 1:1:1 (2cases groups and 1 control group). Randomization was stratified by clinical trial site. The unblinded trial statistician generated randomization sequences (block randomization
with block size of eight) and the unblinded clinical trial staff assigned each
participant to a treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not aware of treatment group which they included
The evaluater is different from surger and she is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol univercity of medical science
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2016-06-15, 1395/03/26
Ethics committee reference number
MUBABOL.REC.1395.146
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
clinical attachment level
Timepoint
at the begining of study and immediately before surgery, 6 and 12 months after sergury
Method of measurement
with periodontal probe
2
Description
probing depth
Timepoint
at the begining of study and immediately before surgery, 6 and 12 months after sergury
Method of measurement
with perodontal probe
3
Description
Radiographic Defect Depth
Timepoint
at the begining of study and immediately before surgery, 6 and 12 months after sergury
Method of measurement
parallel technic by means of digital sensor size 2(Soredex.Helsinki-finland)by Rinndentsply film holder
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : open flap debridement with chitosan with high molecular weight (MW800000-600000)
Category
Treatment - Surgery
2
Description
Intervention group: open flap debridement with chitosan with low molecular weight (MW300000-100000)
Category
Treatment - Surgery
3
Description
Control group: Open flap debridement
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology departmet of Babol dental faculty
Full name of responsible person
Maryam Faghani
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
mary7.pgx87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Associated professer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Associated professer
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Faghani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
mary7.pgx87@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available