Effectiveness of different antimicrobial agents in malodorous prevention in the beginning of prosthetic phase of two-stage implants

Effectiveness of different antimicrobial agents in malodorous prevention in two-stage implants

Current study is a stratified clinical trial (based on gender and age) with equal randomization, controlled, and Triple-blinded which is performed parallel on 51 patients from Implant department of Isfahan University of Medical Sciences. Participants are stratified based on age and gender and randomly assigned to three groups of 17 people. Intervention is done on two of these three groups and the third group is control group.

This randomized and Triple-blinded clinical trial is performed on patients who referred to Implant department of Isfahan University of Medical Sciences for surgical exposure of their two-stage implants.

Entry requirements: Patients for whom the two-stage “snow” system is intended (based on expert opinion); gingival depth between 2 and 3 mm No entry conditions: other implant systems; gingival depth too high or too low

Group 1: 2% Chlorhexidine gel is added to the internal surface of the fixtures. Group 2: 3% Tetracycline ointment is added to the internal surface of the fixtures. Group 3: patients participated in this group are negative controls. No medicine is added to the internal surface of their fixtures.

Outcome which is considered to be evaluated in this study is malodorous released after opening the healing abutments. 0: no malodorous 1: hardly smelled malodorous 2: mild malodorous that is easily smelled 3: moderate malodorous 4: severe malodorous 5: intensive malodorous

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)

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.