]>
IRCT20150210021029N5 IRCT 2021-06-09 Esfahan University of Medical Sciences Effect of atorvastatin gel on GCF cytokines of patients with chronic periodontitis 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 2021-05-22 anticipated 20 Complete https://irct.ir/trial/49269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 chronic periodontitis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data related to Personal information and Indicators examined in the study. All Data can be shared after People have not been identified When: Up to One year after publication of the Article To whom: Researchers working in Academic and Scientific Institutions Conditions: 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 Where to obtain: Applicants can contact this E-mail: skiani.dnt@gmail.com How to obtain: The Project Manager will provide the requested Documents via E-mail no later than One week after receiving the E-mail from the Applicant Comments:
public Sima Kiani
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5542 Simakiani@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Sima Kiani
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5542 Simakiani@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 30 years 60 years Both 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 K05.3 Chronic periodontitis Treatment - Drugs Placebo 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. 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. 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. 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. Esfahan University of Medical Sciences Approved 2021-02-21 Ethics Committee of Isfahan University of Medical Sciences Isfahan university of medical sciences, Hezarjerib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)