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IRCT20241227064183N1 IRCT 2025-02-06 Tabriz University of Medical Sciences Clinical evaluation of the efficacy of nano-emul gel of Atorvastatin on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial) Clinical evaluation of the efficacy of nano-emul gel of Atorvastatin on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial) 2025-02-15 anticipated 50 Complete https://irct.ir/trial/81332 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: n this study, 25 intervention and 25 control envelopes, which were completely identical in appearance, were randomly numbered (from 1 to 50). The allocation sequence was generated by the research assistant using Random Allocation Software (RAS). Each envelope was opaque, sealed, and remained closed until the start of treatment. The distribution of envelopes to patients was done in no particular order and completely randomized. The preparation of envelopes according to the allocation sequence was performed by a person not involved in the treatment process to avoid bias. Patients were matched by age and sex, and this design was done to increase the accuracy and generalizability of the results, Blinding description: For blinding, a sealed envelope will be used and the sealed envelope will be given to the doctor by the patient. In other words, after opening the envelope, the doctor will use atorvastatin nano-emul gel for the wound or will be considered as a control group. Also, the study will be double-blind and the student evaluator and the patient will not know about the case and control areas. 1 Wounded tissue caused by periodontal flap surgery. Intervention 1: Intervention group: The surgical area in the patient's mouth is randomly selected as the intervention group and the study material will used in this area. Intervention 2: Control group: The surgical area in the patient's mouth is randomly selected as the control group, and the study material will not be used in this area. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Maryam Kouhsoltani
Azadi Blvd., Golgasht St., Dentistry Faculty of Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5965 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences scientific Dr. Maryam Kouhsoltani
Dentistry Faculty of Tabriz university of medical sciences, Golgasht St., Azadi Blvd.
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5965 mkoohsoltani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients will be included in the study if they are: aged 18-75 years, in good general health, non-smokers, available during the 12-week study, have periodontitis, as defined by at least two non-adjacent interproximal sites with pocket depths (PPDs) greater than 4 mm or other radiographic evidence such as visible alveolar bone loss, and require periodontal surgery. 18 years 75 years Both Exclusion criteria: Pregnant women, lactating women, patients who have used antibiotics and anti-inflammatory drugs within 1 month before surgery, patients whose systemic disease has directly affected their periodontal disease (such as chronic use of steroids, bisphosphonates, calcitonin, methotrexate, and estrogens in the past 6 months), patients with removable restorations, patients using removable orthodontic appliances, periodontal treatment in the past year, patients who have participated in another study within the past 1 month, patients who have had allergic reactions to hygiene products, patients who are prohibited from eating or drinking fluids for 4 hours due to medical conditions, patients with 5 or more decayed teeth. T81.3 Disruption of wound, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: The surgical area in the patient's mouth is randomly selected as the intervention group and the study material will used in this area. Control group: The surgical area in the patient's mouth is randomly selected as the control group, and the study material will not be used in this area. Clinical variables evaluated after surgery include soft tissue swelling, gum color, pocket probe depth, clinical attachment loss, bleeding index, plaque index. Also, during the first 7 days after surgery, patients will complete a questionnaire to evaluate post-surgery complaints, which includes the amount of pain experienced, the type of pain, the number of painkillers taken, swelling of the mucous membrane and swelling of the face, and swelling and bleeding of the gum. Timepoint: Examining the results of wound healing 1, 4 and 8 weeks following the surgery. Method of measurement: To assess the degree of swelling, the number 0 will be used for no swelling, the number 1 for moderate swelling, and the number 2 for significant swelling. To assess the color of gingiva, in comparison with the opposite side, the numbers 0 for no redness, 1 for moderate redness, and 2 for significant redness will be used. For measuring the depth of the pocket probe and CAL, the reference of these measurements will be from the CEJ. Bleeding index will be measured at 6 levels of the involved teeth and finally a numerical measure will be presented as an average. The presence or absence of bleeding during probing will be recorded with two scales: 0 for no bleeding and 1 for bleeding that is seen between 0 and 30 seconds after probing. The presence or absence of plaque will also be measured with the same scale along the gingival margin. Tabriz University of Medical Sciences Approved 2024-12-10 Ethics committee of Tabriz University of Medical Sciences Research development and coordination center (RDCC), faculty of medicine, Tabriz university of medical sciences, Attar Neyshaburi St., Golgasht, St. Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)