Recruiting
Phase 1

Antibiotics

Sponsor:

Université de Montréal

Code:

NCT04280406

Conditions

Dental Implant Failed

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Azithromycin

Placebo oral tablet

Study Details

Brief 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.

Conditions

Dental Implant Failed

Study ID

NCT04280406

Start date

Feb 25, 2020

Status verified date

Sep, 2022

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Test

- 500mg of azithromycin one hour before implant placement

placebo comparator: control

- identical placebo one hour before implant placement

Interventions

Azithromycin

azithromycin 500mg one hour before implant placement

Placebo oral tablet

identical placebo one hour before implant placement

Primary outcome measure

  • peri-implant crestal bone change [ Time Frame: 4 months, 1 year ]

Central Contacts and Locations

Central contacts

Robert Durand, DMD, MS

514-343-7464robert.durand@umontreal.ca

Ryma Kabir, DMD, MSc

514-343-6111ryma.kabir@umontreal.ca

Locations

Université de Montréal - Faculty of Dentistry - Dental clinics

Recruiting

Montreal, Quebec, Canada, H3T 1J4

Contacts

Robert Durand, DMD, MS

514-343-7464robert.durand@umontreal.ca

Rene Voyer, BS, DMD, MS

514-343-5926rene.voyer@umontreal.ca

Principal Investigator:

Robert Durand, DMD, MS

More Information

Sponsor

Université de Montréal

Last update posted

Sep 7, 2022

Last verified

Sep, 2022

Keywords

  • dental implants
  • antibiotics
  • bone
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2022-09-07.