Clinical and radiographic evaluation of applying 1.2% Atorvastatin gel with plasma rich in growth factor (PRGF) for treatment of class II furcation involvement
Effect 1.2% Atorvastatin gel with plasma rich in growth factor (PRGF) for treatment of class II furcation involvement
Design
Randomized clinical trial, with control group, parallel design, double blind
Settings and conduct
Samples are selected according to the criteria of entry and exit from the Babol periodontal department of Dentistry in easy or accessible manner. The patients and the outcome assessor are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with moderate to severe chronic periodontitis with severe grade II furcation on the buccal or lingual side of the first or second mandibular molar, and the horizontally probing depth of the probe in the affected areas should be greater than or equal to 3mm.
Exit criteria:
Systemic disease, need for prophylactic antibiotics to prevent bacterial endocarditis, use of intermittent drugs with periodontal improvement, smoking, contraindication for periodontal surgery, anatomical complications such as accessory canal, CEP concavity, bifurcation ridge, There is evidence of periapical pathology in the clinical or radiographic profile of the tooth and the likelihood of unacceptable patient consent after the initial periodontal treatment of the patient.
Intervention groups
Use of Atorvastatin1.2% alone
Use of Atorvastatin1.2% plus PRGF
Use of PRGF alone
Debridment alone
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
2017-05-27, 1396/03/06
Expected recruitment end date
2017-07-27, 1396/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic evaluation of applying 1.2% Atorvastatin gel with plasma rich in growth factor (PRGF) for treatment of class II furcation involvement
Public title
Clinical and radiographic evaluation of applying 1.2% Atorvastatin gel with plasma rich in growth factor (PRGF) for treatment of class II furcation involvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe chronic periodontitis with severe grade II fractures on the buccal or lingual side of the first or second mandibular molars
The horizontal probing depth of the probes in the affected areas is greater than or equal to 3mm
Exclusion criteria:
Systemic disease
The need for prophylactic antibiotics to prevent bacterial endocarditis
Use of intermittent drugs with periodontal improvement
smoking
presence of contraindication for periodontal surgery
dental anatomical complications such as accessory canal concavity CEP, bifurcation ridge
Tooth mobility more than Grade II
The presence of decay and filling in the area of forcation
There is evidence of periapical pathology in the clinical or radiographic view of the tooth
Possibility of unaccompanied consent after initial periodontal treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
4
First or second molar of right or left side of mandible
Actual sample size reached:
10
More than 1 sample in each individual
Actual sample size in each individual:
4
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are classified in the intervention group with knowledge of the entire study and informed consent form. The outcome elevator measures the study data without any knowledge about type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences, Dept. of Research and Technology
Street address
University of Medical Sciences, Dept. of Research and Technology Ganjafroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717641367
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
MUBABOL.REC.1396.25
Health conditions studied
1
Description of health condition studied
furcation grade 2 involvement of lower jaw molars
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
grade 2 furcation involvement of lower jaw molars
Timepoint
Immediately before surgery 3 and 6 months after surgery
Method of measurement
periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: Using Atorvastatin1.2% alone in treatment of 6 mandibular molar grade II furcation involvment
Category
Treatment - Surgery
2
Description
Intervention group 2: use of Atorvastatin1.2% plus PRGF in treating 6 mandibular molar grade II furcation involvment
Category
Treatment - Surgery
3
Description
Intervention group 3: Use of PRGF alone in treating 6 mandibular molar grade II furcation involvment
Category
Treatment - Surgery
4
Description
Control group: Debridement alone in treating 6 mandibular molar grade II furcation involvment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Dental University
Full name of responsible person
Sakineh Mohammadpour
Street address
Babol Dental University, Ganjafroz Ave , Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4719
Fax
+98 11 3219 4719
Email
sakine861@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Aliakbar Moghadamnia
Street address
Babol Dental University, Ganjafroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4719
Email
A.moghadamnia@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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol Dental University, Ganjafroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol Dental University. Ganjafroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1229 1408
Fax
+98 11 1229 1093
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
Niloofar Jenabian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol Dental University, Ganjafroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1229 1408
Fax
Email
n.jenabian@mubabol.ac.ir
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