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IRCT20150210021029N4 IRCT 2021-03-02 Esfahan University of Medical Sciences Evaluation of effect of Atorvastatin gel on treatment of periodontal inflammatory disease Comparison of the Atorvastatin Local Gel Application and Placebo on Periodontal Clinical Indices in Patient with Chronic Periodontitis 2020-10-22 anticipated 20 Complete https://irct.ir/trial/50522 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 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 was selected by randomization by coin instrument) Atorvastatin gel is injected and after 6 weeks and 3 months the secondary sampling will be performed. Intervention 2: 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. 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 making people unidentifiable. When: Up to One year after publication of the Article To whom: Researchers working in Academic and Scientific Institutions Conditions: 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 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
Dentistry School, Isfahan University of Medical Sciences, Hezarjerib street, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5542 Simakiani@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Sima Kiani
Dentistry School, Isfahan University of Medical Sciences, Hezarjerib street, 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 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 30 years 60 years Both 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 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 was selected by randomization by coin instrument) Atorvastatin gel is injected and after 6 weeks and 3 months the secondary sampling will be performed. 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. 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). 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). 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). Esfahan University of Medical Sciences Approved 2020-11-01 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezarjerib street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)