The effect of systemic antibiotics on clinical and patient-centered outcomes of implant therapy- a randomised controlled clinical trial

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The aims of the study are to determine the effect of various systemic antibiotic prophylaxis regimes on patient-centred outcomes and perceptions, postsurgical complications in patients undergoing standard oral implant therapy. The hypothesis is that the use of both peri-operative and/or post-operative systemic antibiotics does not provide additional benefits, in terms of decreasing postsurgical complications. 336 medically healthy adults who are consecutively admitted to 7 study centres for standard oral implant therapy will be randomly assigned to one of the 4 groups (3 test and 1 control groups). Pre-operative antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement will be prescribed to test group 1 (positive control), post-operative antibiotics of 2 g amoxicillin following implant placement for test group 2, and pre-operative antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement and 500 mg thrice daily on days 2 through 3 after standard implant placement for test group 3. The control group will be given a placebo tablet of 2g 1 hour prior to standard implant placement without any antibiotics. Subjects will be examined clinically by blinded examiners at 1 week, 2 weeks, 4 weeks and 8 weeks from implant installation for post-operative complications. In addition, Visual analogue scores (VAS) on pain, swelling, bruising and bleeding will be obtained from the patients from day 1 through day 7 and 14. The present study will answer an important clinical question with regards to the recommendation of antibiotic usage to prevent post-operative complications (suppuration) with oral implant placement and to recommend a protocol of pre-, peri- or post-operative administration of antibiotics, if required.

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