Evaluation of the Atorvastatin Local Gel Application Effectiveness on Periodontal Clinical Indices in Patient with Chronic Periodontitis
Design
Clinical trial with control group, 2 arm parallel group, Double-blinded, randomized, phase 2 on 40 pockets in 20 patients, randomization was done with random numbers table.
Settings and conduct
Place: Specialized department of the Faculty of Dentistry, Isfahan University of Medical Sciences. Conduct: Assignment of each of the two quadrants from the mouth of each patient by split mouth protocol into two areas one receiving treatment and the other being control. Blinding: Patient and therapist are both blind to the intervention because Atrovastatin and placebo gel have A and B labels and aren't identifiable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Systemic health; age of 30-60 years old; have mild to moderate chronic periodontitis; presence of at least 20 teeth; presence of at least 2 pockets with 4-7 mm of probing depth and CAL of equal to or greater than 3 mm.
Non-inclusion criteria: Smoking; pregnancy; use of cholesterol-lowering drugs or antibiotic medications in the past 1 month; presence of orthodontic appliances.
Intervention groups
Intervention group: Atorvastatin; Atorvastatin gel will be applied for intended pocket by a blunt tip insulin syringe.
Control group: Placebo; placebo gel will be applied for intended pocket by a blunt tip insulin syringe.
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
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Atorvastatin Local Gel Application and Placebo on Periodontal Clinical Indices in Patient with Chronic Periodontitis
Public title
Evaluation of effect of Atorvastatin gel on treatment of periodontal inflammatory disease
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 bridge, crown or orthodontic braces in gel application area
Having at least 2 pockets with 4-7mm of probing depth and CAL of equal to or greater than 3mm
Having general health
Exclusion criteria:
Having systemic diseases
Pregnancy and lactation
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
Presence of symptoms of corona virus disease or similar symptoms
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
Participants selection in the study will be performed by simple randomization method, individually and with random number table tools.
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 individuals' quadrant for Intervention or Control will be randomly performed with coin instruments.In such a way that for both quadrants which their numbers are accidentally put in the list, we drop a coin and if it's head for the first quadrant gel A and for the second, gel B will be applied and vice versa if it is tails.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: They don't know which side of their mouth is taking medication or 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: All data is is converted to numbers as code, without defining code in the file given to the analyzer.
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 street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.462
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
Pocket Depth
Timepoint
At baseline (before the intervention) and at 6 weeks and 3 months after gel application
Method of measurement
Williams Periodontal Probe (Hu-Friedy®, USA)
2
Description
Clinical Attachment Level
Timepoint
At baseline (before the intervention) and at 6 weeks and 3 months after gel application
Method of measurement
Williams Periodontal Probe (Hu-Friedy®, USA)
3
Description
Modified Sulcular Bleeding Index
Timepoint
At baseline (before the intervention) and at 6 weeks and 3 months after gel application
Method of measurement
Williams Periodontal Probe (Hu-Friedy®, USA)
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 was selected by randomization by coin instrument) Atorvastatin gel is injected and after 6 weeks and 3 months the secondary sampling will be performed.
Category
Treatment - Drugs
2
Description
Control group: After the primary sampling, scaling and oral hygiene education, by split-mouth protocol for each patient in one quadrant (which was selected by randomization by coin instrument) placebo gel is injected and after 6 weeks and 3 months the secondary sampling will be performed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry; Isfahan University of Medical Sciences
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
Vice chancellor for Research; Isfahan Dental School; Isfahan University of Medical Sciences, Hezarjerib street
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
Dentistry School, Isfahan University of Medical Sciences, Hezarjerib street, 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
Dentistry School, Isfahan University of Medical Sciences, Hezarjerib street, 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
Dentistry School, Isfahan University of Medical Sciences, Hezarjerib street, 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 making people unidentifiable.
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
In 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