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IRCT20210408050898N1 IRCT 2021-04-27 Oroumia University of Medical Sciences ٍEffects of Metronidazole gel and tablets in gingival disease treatment Effects of local and systemic Metronidazole as adjunctive treatment in patients suffering from chronic periodontitis 2021-05-01 anticipated 30 Complete https://irct.ir/trial/55495 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients included in the study will be divided into a control group and two intervention groups based on the pre-generated randomization sequence, which is random and unpredictable. To divide the samples, the block randomization method with the blocks size of 3 and 6 will be used; In this way, by block random number generation software, a random sequence will be generated according to the required sample size for the three groups. First, all the cases in which the three letters A, B, and C can be put together in blocks of 3 and 6 are generated and randomly selected by placing a block between the blocks, and from the layout pattern of that block to patient classification will be used; Then this block will be placed in the main container and we will select another block again. All the blocks of 3 and 6 will be placed in one container. Sealed Envelope software will be used to perform this process, Blinding description: The person reviewing the results of the use of different forms of medication in the participants, as well as the person analyzing the data, do not know the treatment method and the form of medication used in each participant. 3 Chronic Periodontitis. Intervention 1: Control group: Receiving of Scaling and Root Planing by ultrasonic cavitron. Intervention 2: First intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron ,twenty 250 mg tablets Metronidazole tablets made by Tehran Shimi Company are prescribed every eight hours for a week. Intervention 3: Second intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron , 0.75% Metronidazole gel made by Pars Daroo Company is placed inside the pockets included in the study until the pocket is completely filled by a syringe with a non-cutting end needle. The gel is reused one week, two weeks and three weeks later. 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 more information.
public Ehsan Hooshyar
َAlborz Dental Clinic , Badali Ave , Alborz Blvd , Urmia
Urmia Iran (Islamic Republic of) 5719736191 +98 44 3336 3590 houshyar.e@umsu.ac.ir Oroumia University of Medical Sciences scientific Ehsan Hooshyar
َAlborz Dental Clinic , Badali Ave , Alborz Blvd , Urmia
Urmia Iran (Islamic Republic of) 5719736191 +98 44 3336 3590 houshyar.e@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient diagnosed with chronic periodontitis with at least three non-adjacent pockets with probing depth equal to or greater than 4 mm. Patients with systemic health. Patients who have not taken any anti-inflammatory drugs or antibiotics in the last six months. Patients with at least 15 teeth (except third molars) in their mouth. Patients with proper cooperation. Patients who have signed an informed written consent form. 30 years no limit Both Patients with medical problems who need antibiotic prophylaxis or treatment intervention. Patients who have had periodontal treatment in the last six months. Patients who have used drugs that affect their periodontal status (such as antibiotics, anti-inflammatory drugs, anticonvulsants, immunosuppressive drugs, and calcium channel blockers) in the last six months. Patients who have undergone orthodontic treatment. Pregnant and lactating patients. Patients with systemic diseases such as diabetes and immunological disorders. O’Leary plaque index more than 15% after proper oral hygiene training. History of Metronidazole allergy. K05.3 Chronic periodontitis Treatment - Devices Treatment - Drugs Treatment - Drugs Control group: Receiving of Scaling and Root Planing by ultrasonic cavitron First intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron ,twenty 250 mg tablets Metronidazole tablets made by Tehran Shimi Company are prescribed every eight hours for a week. Second intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron , 0.75% Metronidazole gel made by Pars Daroo Company is placed inside the pockets included in the study until the pocket is completely filled by a syringe with a non-cutting end needle. The gel is reused one week, two weeks and three weeks later. Pocket Probing Depth. Timepoint: At the beginning of the study (before the intervention) and three months after the intervention. Method of measurement: Periodontal Probe. Clinical Attachment Level. Timepoint: At the beginning of the study (before the intervention) and three months after the intervention. Method of measurement: Periodontal Probe. Bleeding On Probing. Timepoint: At the beginning of the study (before the intervention) and three months after the intervention. Method of measurement: Visual. Oroumia University of Medical Sciences Approved 2020-12-23 Ethics committee of Urmia University of Medical Sciences Ethics committee of Urmia University of Medical Sciences, Urgans Ave, Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)