The Effect of Preoperative Antibiotics on Peri-implant Healing

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Université de Montréal
• Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin

Criteria

Inclusion Criteria:

• Periodontally healthy remaining dentition or presenting with mild gingivitis with adequate oral hygiene.

• Presence of a partially edentulous alveolar ridge that is planned to be restored with no more than 2 implants.

• To have 1 or 2 implants restored with a crown or fixed bridge.

• Presence of a non-infected site.

• Presence of enough bone and soft tissue for the implant to be placed without additional bone augmentation in a 1-stage approach (with healing abutment).

• Implants 6 mm long or longer.

• Subjects able and willing to provide written informed consent and comply with study procedures.

Exclusion Criteria:

• Subjects taking regular analgesics or antidepressants.

• Smoking 10 cigarettes/cigars or more per day.

• Marijuana smokers.

• Use of vaping devices or e-cigarettes

• Drug abuse.

• Completely edentulous individuals.

• Pregnant and nursing women.

• Allergies to macrolides, and/or non-steroidal anti-inflammatory analgesics.

• Active peptic ulcers or susceptibility to peptic ulcers.

• Any systemic or local immunodeficiency.

• Any blood coagulation impairment or taking anticoagulants (ex.: Coumadin).

• Presence of uncontrolled periodontitis or poor oral hygiene.

• Presence of any acute oral infection.

• Presence of uncontrolled diabetes or other systemic diseases.

• Previous radiation therapy in the head and neck area.

• Intravenous bisphosphonates.

• Oral bisphosphonates intake for more than 4 years.

• Long-term intake of corticosteroids.

• Need for routine prophylactic antibiotics prior dental surgery.

• No intake of antibiotics 3 months prior surgery.