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IRCT20210705051795N1 IRCT 2021-08-09 Esfahan University of Medical Sciences Effect of some antimicrobial agents in malodorous prevention in dental implants Effectiveness of different antimicrobial agents in malodorous prevention in the beginning of prosthetic phase of two-stage implants 2021-08-06 anticipated 51 Complete https://irct.ir/trial/57610 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Initially, 51 eligible participants enter the study. These people are categorized individually by "stratified randomization" according to the layers below. Subjects are divided into 2 groups based on gender. Then each group is divided to 3 groups based on age (less than 40, between 40 and 60, more than 60 years old). Eventually we will have 6 groups divided by age and gender. Now members of each group must be equally divided into 3 groups of intervention as following: Names of participants of all 6 groups are written on separate sealed papers. Papers are separated one by one by "drawing lots". The first paper belongs to group 1 of intervention, the second paper belongs to group 2, and the third paper belongs to the control group. This procedure is repeated for all participants of each group and then for all 6 groups. Outcome assessors only attend the malodorous assessment session. They will not know about grouping and the medication used for each patient. (Allocation concealment), Blinding description: Participants and therapists (dentists who add the antimicrobial agents into the fixtures in surgery session) will not know how the patients were grouped. Moreover, participants' list and medication used of each will not be shown to the outcome assessors. 3 Malodorous. Intervention 1: First group of intervention: In the exposure surgery session, before the healing abutments of participants are screwed, 2% Chlorhexidine gel (Morvabon brand; made in Morvabon Company in Iran) is added to the internal surface of implant fixtures applying with a sterile micro-brush. Intervention 2: Second group of intervention: In the exposure surgery session, before the healing abutments of participants are screwed, 3% Tetracycline ointment (made in Hakim Company in Iran) is added to the internal surface of implant fixtures applying with a sterile micro-brush. Intervention 3: Control group: For participants of this group exposure surgery is done as usual and no additional intervention is performed. 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 extra information available
public Amirhossein Fathi
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 amir_alty@yahoo.com Esfahan University of Medical Sciences scientific Amirhossein Fathi
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 amir_alty@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Usage of 2-stage "snow" implant system Gingival depth of 2 to 3 mm no limit no limit Both Uncontrolled systemic disease or history of specific medical condition Smoking habit or use of alcohol Current periodontal disease Prevention Prevention N/A First group of intervention: In the exposure surgery session, before the healing abutments of participants are screwed, 2% Chlorhexidine gel (Morvabon brand; made in Morvabon Company in Iran) is added to the internal surface of implant fixtures applying with a sterile micro-brush. Second group of intervention: In the exposure surgery session, before the healing abutments of participants are screwed, 3% Tetracycline ointment (made in Hakim Company in Iran) is added to the internal surface of implant fixtures applying with a sterile micro-brush. Control group: For participants of this group exposure surgery is done as usual and no additional intervention is performed. The primary consequence variable is the "amount of Malodorous". Timepoint: Evaluation of Malodorous is performed 3 weeks after the intervention. Method of measurement: Evaluation is performed based on clinical observation or organoleptic method. Esfahan University of Medical Sciences Approved 2021-07-20 Ethics committee of Isfahan University of Medical sciences Vice Chancellor for Research and Technology-No.4, Hezar Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)