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IRCT20140817018834N8 IRCT 2021-06-10 Vice Chancellor for research of Mashhad University of Medical Sciences Evaluation of the effect of antibiotic prophylaxis in implant surgery with guided bone regeneration. Evaluation of the effect of antibiotic prophylaxis on clinical and patient reported outcome and inflammation-related indicators of oral implant therapy with guided bone regeneration. 2021-06-13 anticipated 100 Complete https://irct.ir/trial/56364 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be block. Patients will be randomly allocated in to the intervention and control groups by block randomization technique. A number of two blocks (A and B) will be considered. With the help of random numbers, a random number will be assigned to each group and this will determine the type of intervention. For blindness with the help of random number and code for each patient, a person other than the patient surgeon puts the type of intervention in the envelope. The type of intervention (use of prophylaxis or not ) is recommended to the patient , Blinding description: Due to the design of the study, it is not possible to blind the participants, principal investigator and clinic staff, and Each person's data are made available to the data analyzer and the Outcome assessor without knowing the case group or being in control. 3 Horizontal alveolar bone defects.. Intervention 1: Intervention group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group 2 gr amoxicillin will be prescribed one hour before treatment. After surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed. Intervention 2: Control group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group, no prophylactic antibiotic will be prescribed before treatment. after surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed. Yes - There is a plan to make this available What will be shared: The data is related to the main consequence after unidentifiable people are shared. When: 6 month after printing the results. To whom: Researchers working in academic and scientific institutions. Conditions: If you are to submit a article to a journal, they will be asked to receive the data. Where to obtain: Person responsible for scientific study. nasran@mums.ac.ir How to obtain: Sending an email to the given address and waiting time to receive a response less than a month. Comments:
public Nahid Nasrabadi
Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad, Razavi khorasan province
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 nasran@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Nasrabadi
Mashhad faculty of dentistry, Vakil Abad Blv , Mashhad, Razavi khorasan province
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 nasran@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) • An age range of 20 to 50 years • The extent of the lesion (horizontal bone augmentation) is about one or two teeth • No previous surgical procedures have been initiated in the specific area • The patient's informed consent •Absence of systemic diseases that interfere healing process, such as diabetes • Non smoker •Do not take drugs interfere with the treatment process, such as corticosteroids • Dehiscence defects in buccal surface of the implant 20 years 50 years Both • Do not refer for routine follow up visits • Patients who are allergic to amoxicillin • The presence of severe infection in the oral cavity • Wound opening during bone transplantation surgery k08.2 Atrophy of edentulous alveolar ridge Treatment - Drugs Treatment - Drugs Intervention group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group 2 gr amoxicillin will be prescribed one hour before treatment. After surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed. Control group: In patients who are candidates for implant placement, the guided bone regeneration treatment will be performed using one type of membrane and one type of bone graft. In this group, no prophylactic antibiotic will be prescribed before treatment. after surgery, amoxicillin 500 mg (Abidi) every 8 hours for 7 days and ibuprofen 400 mg every 6 hours for 5 days will be prescribed. Pain. Timepoint: 1-3-7 days after surgery. Method of measurement: The patient is asked about the amount of pain by telephone using the visual analogue scale index on the first, third, and seventh days, and the patient is asked to rate their pain experience on a scale from 0 to 10 . Swelling. Timepoint: 1_3_7 days after surgery. Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of swelling. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo. Bleeding. Timepoint: 1_3_7 days after surgery. Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of bleeding. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo. Hematoma. Timepoint: 1_3_7 days after surgery. Method of measurement: On the first, third and seventh day, the patient is asked about the presence or absence of hematoma. due to special conditions in COVID-19 prevalence and attracting patient involvement and cooperation, On the third day, the patient will be examined remotely by sending a full face photo. Implant survival. Timepoint: 3 months after surgery. Method of measurement: Clinical and radiography examination. Vice Chancellor for research of Mashhad University of Medical Sciences Approved 2021-05-12 Ethics committee of Mashhad University of Medical Sciences_Mashhad faculty of dentistry Mashhad faculty of dentistry, Vakil Abad Blv, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)