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IRCT20220608055108N1 IRCT 2023-01-03 Shiraz University of Medical Sciences Comparison of the effect of green tea mouthwash with normal saline on the complications of impacted wisdom tooth surgery Comparison of the effect of green tea mouthwash with normal saline on swelling and pain caused by impacted wisdom tooth surgery in patients 2022-11-22 anticipated 24 Complete https://irct.ir/trial/64256 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Quadruple blocks including two allocations for the intervention group and two allocations for the control group are considered. Six possible modes of permuting treatments are listed and each is written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 24 participants. The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each card a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment, Blinding description: The professor of surgery department is the one who performs wisdom tooth surgery. He writes down what mouthwash he has prescribed for each patient. Patients of both participating groups are treated with a certain dose of painkillers and antibiotics. In both intervention and control groups, green apple flavoring is added to the mouthwash so that the patients are blinded. The student is responsible for measuring the results. A statistician analyzes the data. The student and the statistician are blinded to the type of mouthwash prescribed for the patients. Since the outcome analyzer will be different from the one who prescribed the mouthwashes, the outcome assessor will be blinded. 3 Implanted wisdom tooth surgery. Intervention 1: Intervention group: Green tea mouthwash is made by Irsha company. The surgeon removes the mouthwash label and adds green apple flavoring to it. The intervention period is one week. After the surgery, mouthwash is started. Mouthwash is used 4 times a day. Every time, 20 ml of mouthwash is swirled in the mouth for 30 seconds. How to use is explained to the patient orally and in writing. Complications after wisdom tooth surgery appear in the first week after the surgery, and we intend to check the effect of green tea mouthwash on the recovery process by checking on the 1st, 3rd and 7th days. Intervention 2: Control group: The normal saline mouthwash used is made in Irsha company . The surgeon removes the mouthwash label and adds green apple flavoring to it. The intervention period is one week. After the surgery, mouthwash is started. Mouthwash is used 4 times a day. Every time, 20 ml of mouthwash is swirled in the mouth for 30 seconds. How to use is explained to the patient orally and in writing. Complications after wisdom tooth surgery appear in the first week after the surgery, and we intend to check the effect of green tea mouthwash on the recovery process by checking on the 1st, 3rd and 7th days. Yes - There is a plan to make this available What will be shared: All collected data will be shared after deidentification of participants. When: The data can be accessed 2 months after the results are published in the international journal. To whom: Students, professors and researchers of companies active in the mouthwash industry Conditions: By citing the source and with a commitment not to disclose individuals privately Where to obtain: Refer to dental.sums.ac.ir . How to obtain: The researchers in academic institutions can send email to responsible person and request information. Comments:
public Shila Shahsavari pour
Shiraz Dental School .,corner of Mehr St., Qasrdasht St., Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 shahsavari_sh@sums.ac.ir Shiraz University of Medical Sciences scientific Shila Shahsavari pour
Shiraz Dental School .,corner of Mehr St., Qasrdasht St., Shiraz
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3626 3193 shahsavari_sh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with impacted third molars similarly in terms of occlusion Age 20 to 35 years No systemic disease No Temporomandibular joint problems and no mouth opening restrictions Non-smoker No pregnancy 20 years 35 years Both Patient non-cooperation Z98.818 Other dental procedure status Treatment - Drugs Placebo Intervention group: Green tea mouthwash is made by Irsha company. The surgeon removes the mouthwash label and adds green apple flavoring to it. The intervention period is one week. After the surgery, mouthwash is started. Mouthwash is used 4 times a day. Every time, 20 ml of mouthwash is swirled in the mouth for 30 seconds. How to use is explained to the patient orally and in writing. Complications after wisdom tooth surgery appear in the first week after the surgery, and we intend to check the effect of green tea mouthwash on the recovery process by checking on the 1st, 3rd and 7th days. Control group: The normal saline mouthwash used is made in Irsha company . The surgeon removes the mouthwash label and adds green apple flavoring to it. The intervention period is one week. After the surgery, mouthwash is started. Mouthwash is used 4 times a day. Every time, 20 ml of mouthwash is swirled in the mouth for 30 seconds. How to use is explained to the patient orally and in writing. Complications after wisdom tooth surgery appear in the first week after the surgery, and we intend to check the effect of green tea mouthwash on the recovery process by checking on the 1st, 3rd and 7th days. Pain. Timepoint: Before intervention: one day after surgery. After intervention: one week after surgery. Method of measurement: Pain: According to the patient's measurement is measured by visual analog scale index. In this way, the patient is asked to rate his pain from 1 to 10, where 1 is the lowest pain and 10 is severe. Swelling. Timepoint: We measure the patient's swelling one day after the surgery, which is before the intervention, and one week after the intervention. Method of measurement: Swelling: The distance from the ear tragus to the nasal alar, the ear tragus to the angle of the mandible, the angle of the mandible to the alar of the nose, will be measured by a caliper before surgery. Shiraz University of Medical Sciences Approved 2022-06-22 Shiraz Faculty of Dentistry Ethics Committee Shiraz Dental School .,corner of Mehr St., Qasrdasht St., Shiraz shiraz Fars Iran (Islamic Republic of)