The Effect of Preoperative Antibiotics on Peri-implant Healing
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Introduction: In order to minimize postoperative morbidity and failures of dental implant
therapy, several antibiotic regimens have been proposed in the literature. However, the
extensive use of antibiotics in health care has been debated due to the adverse effects and
bacterial resistance. Furthermore, the impact of preoperative antibiotics on peri-implant
bone level is still not clear.
Objectives: The primary objective of this study will be to assess whether giving preoperative
antibiotics (azithromycin 500mg) after implant placement over 7 days will influence
peri-implant crestal bone levels after 4 months in healthy patients undergoing
platform-switched implant placement. The secondary objectives will be to evaluate
postoperative pain severity, surgery-associated morbidities, and 1-year implant survival
rate.
Methods: Fifty individuals will be recruited in a double-masked 2-arm randomized clinical
trial. Participants in the intervention group will receive 500mg of azithromycin 1 hour
before implant placement. Participants in the control group will take one placebo 1 hour
preoperatively. The changes in mesial and distal crestal bone level (primary outcome) will be
measured at baseline and 4-month follow-up using standardized periapical radiographs. Pain
severity and surgery-associated morbidities (secondary outcomes) will be evaluated by
clinical examinations and self-administered questionnaires. Implant survival rate will be
assessed at the 1-year follow-up. Descriptive and bivariate analyses will be used to analyze
the data. A P value ≤ 0.05 will be considered statistically significant.
Clinical relevance: This study will be the first placebo-controlled double-blinded randomized
clinical trial studying the effect of preoperative azithromycin on radiographical, clinical
and patient-based outcomes after implant surgery. This type of design will reduce as much as
possible the risk of bias and increasing the quality of evidence. The results from this study
might help provide guidelines for clinicians that will optimize implant survival rate while
decreasing antibiotics exposure to patients undergoing straightforward implant surgery.
Phase:
Phase 1
Details
Lead Sponsor:
Université de Montréal
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal