Evaluation of the effect of local Atorvastatin gel application on levels of gingival crevicular fluid cytokines IL-17 and TGF-β in patients with chronic periodontitis and comparison with placebo
Evaluation of the effect of Atrovastatine gel application on levels of GCF cytokines IL-17 and TGF-β of patients with chronic periodontitis
Design
A clinical trial with a control group, 2 arm parallel-group, Double-blind, randomized, phase 2 on 40 pockets in 20 patients, randomization was centralized with randomized number table
Settings and conduct
Place: specialized department of the faculty of dentistry, University of Isfahan. Conduct: assignment of each of the two quadrants from the mouth of each patient by splitting mouth protocol into two areas one receiving treatment and the other, would be as control. Blinding: patient and therapist are both blinded because Atorvastatin and placebo gel has A and B labels.
Participants/Inclusion and exclusion criteria
Inclusion criteria: systemic health; aged 30-60 years; have mild to moderate chronic periodontitis; the presence of at least 20 remaining teeth; the presence of at least 2 pockets with 4-7 mm of probing depth and CAL of equal to or greater than 3 mm. Exclusion criteria: smoking; pregnancy; use of cholesterol-lowering drugs or antibiotic medications in the past 1 month; the presence of orthodontic appliances.
Intervention groups
Intervention group: Atorvastatin gel will be applied to the intended pocket by a blunt tip insulin syringe. Control group: placebo gel will be applied to the intended pocket by a blunt tip insulin syringe.
Main outcome variables
IL-17 and TGF-β levels.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021029N5
Registration date:2021-06-09, 1400/03/19
Registration timing:registered_while_recruiting
Last update:2021-06-09, 1400/03/19
Update count:0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Sima Kiani
Name of organization / entity
Department of Periodentology, dental school, Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2842
Email address
simakiani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local Atorvastatin gel application on levels of gingival crevicular fluid cytokines IL-17 and TGF-β in patients with chronic periodontitis and comparison with placebo
Public title
Effect of atorvastatin gel on GCF cytokines of patients with chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having mild to moderate chronic periodontitis (bone crest distance from CEJ>2, Clinical Attachment Loss≥3)
Having at least 20 teeth
Not having a bridge, crown, or orthodontic braces in the gel application area
Having at least 2 pockets with 4-7mm of probing depth and CAL of equal to or greater than 3mm
Exclusion criteria:
Having systemic diseases
Nonconformity of the prescribed diet
Pregnancy and lactation
Showing coronavirus disease symptoms or similar symptoms
Receiving periodontal treatment and/or usage of antibiotics during 1 month before treatment
Presence of aggressive periodontitis and systemic conditions affecting the periodontal condition
Malnutrition and impaired immune status
Smoking
Using statins or allergy to them
Using drugs that affect oral tissues
Use of antibiotics
Use of cholesterol-lowering drugs such as statins
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Each person has one side of the mouth as a Control and the other side as an example of treatment
Randomization (investigator's opinion)
Randomized
Randomization description
Participant selection in the study will be performed by simple randomization method, individually and with random numbers table tool.
In this way, a number will be written in front of the name of each person from the list of clients, then a table will be designed based on the sample size of the study, and we'll blindly touch a number of table numbers. The selected numbers will be included in the study if they are eligible after the examination. The intervention will be performed in a parallel design, and the choice of a quadrant in each individual for intervention or as control will be randomly performed with coin instruments. In such a way that we drop a coin and for the first quadrant, the head means gel A and for the second, gel B will be applied and vice versa if it is tail.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: participants will not know which side of their mouth will take medication or a placebo
Care provider and investigator: In terms of packaging, color, and consistency, the pharmaceutical gel and placebo are completely similar and are named with the letters A and B for each bottle.
Data analyser: Data is evaluated as a number without specifying the position of the gel and the Placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.729
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
Mean IL-17 level
Timepoint
At baseline (before the intervention) and at 3 months after gel application
Method of measurement
ELISA Il-17 Human Kit
2
Description
Mean TGF-β level
Timepoint
At baseline (before the intervention) and at 3 months after gel application
Method of measurement
ELISA TGF-β Human Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the primary sampling, scaling and oral hygiene education, by split-mouth protocol for each patient in one quadrant (which will be selected by randomization by coin) Atorvastatin gel will be injected once into the depth of sulcus of the considered tooth and after 6 weeks and 3 months the secondary sampling will be performed.
Category
Treatment - Drugs
2
Description
Intervention group: After the primary sampling, scaling and oral hygiene education, by split-mouth protocol for each patient in one quadrant (which will be selected by randomization by coin) Placebo gel will be injected once into the depth of sulcus of the considered tooth and after 6 weeks and 3 months the secondary sampling will be performed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, School of Dentistry
Full name of responsible person
Sima Kiani
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3669 2588
Email
research@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Research vice chancellor, Isfahan Dental School, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 5512
Email
research@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sima Kiani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 5542
Email
Simakiani@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Kiani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 5542
Email
Simakiani@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Kiani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 5542
Email
Simakiani@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to Personal information and Indicators examined in the study. All Data can be shared after People have not been identified
When the data will become available and for how long
Up to One year after publication of the Article
To whom data/document is available
Researchers working in Academic and Scientific Institutions
Under which criteria data/document could be used
n addition to mentioning the Name and Academic affiliation, the Applicant must have signed a letter stating that He or She does not intend to publish or use any of our study Data in Person
From where data/document is obtainable
Applicants can contact this E-mail: skiani.dnt@gmail.com
What processes are involved for a request to access data/document
The Project Manager will provide the requested Documents via E-mail no later than One week after receiving the E-mail from the Applicant