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IRCT20201221049786N1 IRCT 2021-02-13 Esfahan University of Medical Sciences The effect of antibiotic therapy on oral health-related quality of life in patients Comparison of the effectiveness of complementary antibiotic and standard treatment on oral health-related quality of life in patients with chronic periodontitis 2021-01-31 anticipated 50 Complete https://irct.ir/trial/53189 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization is done using the random numbers table. Numbers are read from right side to left side. Even numbers are attributed to treatment group and odd numbers are attributed to the control group. None the patients nor the surgeons will be aware of the randomization results, Blinding description: This study is a double blind clinical trial. To ensure complete blindness of patients and surgeons, the drug substance is extracted from Amoxicillin capsules. Empty caps are filled by Placebo and they are given to patients in control group. The Placebo of Metronidazole is also prescribed for patients in control group. The bottles containing the drugs are the same in both of the treatment and control groups. 3 Chronic periodontitis. Intervention 1: Intervention group: prescription of Amoxicillin 500 mg and Metronidazole 250 mg (Daroopakhsh Co. made in Iran) every 8 hour for 10 days. Intervention 2: Control group: Placebo similar to Amoxicillin capsule and Metronidazole tablet (made in Pharmacy School of Isfahan University of Medical Sciences) every 8 hour for 10 days. Yes - There is a plan to make this available What will be shared: Making all of the information undetectable, cases related to the main outcomes studied and complete filled forms and questionnaires will be available. When: Start of access from 2022 To whom: Researchers working in academic and scientific institutions Conditions: Usage of these data for systematic reviews and meta analyses are permitted. Where to obtain: To gain any information, please contact with email (parastooparhizkar@ymail.com) or phone number (09387300175 ). How to obtain: After consultation with officials, the desired files will be sent. Comments:
public Jaber Yaghini
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5570 j_yaghini@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Jaber Yaghini
Dental school, Isfahan University of Medical Sciences, Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5570 j_yaghini@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult healthy patients over 18 years with moderate to severe generalized chronic periodontitis Bearing at least 16 teeth in oral cavity 18 years 50 years Both Having any other periodontal treatments during the past 6 months History of allergy to Lidocaine, Amoxicillin and Metronidazole Having Corticosteroid or Antibiotic therapy Consuming hormonal drugs and Contraceptives Pregnancy in women based on self-expression K05.3 Chronic periodontitis Treatment - Drugs Placebo Intervention group: prescription of Amoxicillin 500 mg and Metronidazole 250 mg (Daroopakhsh Co. made in Iran) every 8 hour for 10 days Control group: Placebo similar to Amoxicillin capsule and Metronidazole tablet (made in Pharmacy School of Isfahan University of Medical Sciences) every 8 hour for 10 days Oral health related quality of life. Timepoint: Before surgical procedure, 30 and 90 days after antibiotic therapy. Method of measurement: Oral health impact profile(OHIP-14) and Oral impact on daily performance (OIDP) questionnaire. Esfahan University of Medical Sciences Approved 2020-11-17 Ethics committee of Isfahan University of Medical Sciences floor 5; No. west-135; Miremaad 4; 24 alley; South Abounaiem street; Kaveh street Isfahan Isfehan Iran (Islamic Republic of)