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IRCT20221021056257N1 IRCT 2022-11-09 Tabriz University of Medical Sciences Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial) Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial) 2022-11-12 anticipated 30 Complete https://irct.ir/trial/66471 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The sample selection method in the stage of allocating the type of treatment is randomized controlled sampling. In this method, the list of qualified people will be entered into Excel software and people will be randomly selected from the statistical population, Blinding description: For blinding, Sealed envelope will be used and it will be given to the doctor by the patient. In other words, in this study, the surgical site is selected randomly and after opening the envelope, the doctor is going to use a gel containing spirulina bioactive compounds for the wound on one side, and the wound on the other side is considered as a control, and no special substance will be used. Also, the study is double-blind, and the evaluating student and the patient will not know about the case and the control. 1 Wounded tissue caused by periodontal flap surgery. Intervention 1: Intervention group: One of the surgical sites will be randomly selected as the intervention group and the tested substance will be used in this area. Intervention 2: Control group: the other surgical site will be randomly selected as the intervention group and no substance will 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) Having a favorable general health condition Being available during the 12 weeks of study Non- smoker patients Diagnosis of periodontitis, as defined by at least three non-contiguous interproximal pockets with pocket depth (PPDs) greater than 4mm or other radiographic evidence such as alveolar bone loss Patients who show PPD ≥ 6mm after non-surgical treatment and periodontal surgery is indicated. 18 years 75 years Both Pregnant women People who had used antibiotics and anti-inflammatory drugs within a month before surgery Patients who use orthodontic appliances Patients using the removable prosthesis Patients with intraoral pathological conditions Patients with 5 or more decayed teeth Patients who had participated in another study during the last 1 month Patients with a history of allergic reaction to health care products Patients who are forbidden to eat or drink liquids for 4 hours due to medical conditions T81.3 Disruption of wound, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: One of the surgical sites will be randomly selected as the intervention group and the tested substance will be used in this area. Control group: the other surgical site will be randomly selected as the intervention group and no substance will 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: In order to check the amount of Swelling, the number 0 will be used for the absence of Swelling, the number 1 for moderate Swellingand 2 for significant Swelling. In order to evaluate the color of the gums, while comparing with the opposite side, the numbers 0 will be used for no redness, 1 for moderate redness and 2 for significant redness. To measure the depth of the probe pocket and CAL, the reference of these measurements will be from the Cementoenamel Junction. Bleeding index and Plaque index will be measured on 6 surfaces of the involved teeth and finally the measurements will be presented as an average. The presence or absence of bleeding during the probe will be recorded with two scales: 0 for no bleeding and 1 for bleeding. The presence or absence of plaque will also be measured with the same scale along the gingival margin. Also, to measure the variables of the questionnaire, in order to check the level of pain, the Visual Analogue Scale, which is a visual analog index with a degree of pain from 0 to 10, will be used. The amount of swelling of the mucous membrane and face will be asked with two options: no swelling and high swelling, and the presence or absence of bleeding in the area after surgery will be asked. The patient is requested not to refer to the information of the previous days when completing the questionnaire daily. Tabriz University of Medical Sciences Approved 2022-10-10 Research Ethics Committees 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)