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Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants

NCT01851681 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-04

No results posted yet for this study

Summary

In order to prevent infections and complications, it has been initially established with the dental implant placement protocol that pre- and post-operative antibiotics should be prescribed to the patient receiving dental implants. There have been many antibiotic regimens used in the attempt to minimize the risks of infections and consequently, increasing the survival rate of dental implants placement procedures. However, issues about bacterial resistance have been raised recently concerning the extensive use of antibiotics. The primary objective of this study is to find out whether giving antibiotics before or after implant placement would significantly influence crestal bone loss around dental implants. One study group will receive one dosage of antibiotics before implant placement followed by post-operative intake of antibiotics for 7 days. Another group will receive the antibiotics in one single preoperative dose followed by an identical placebo for 7 days. Questionnaires for pain and interference with daily activities assessment to be filled for the first postoperative week will be distributed to participants. Signs of postoperative morbidity will be recorded at 1 and 3 weeks following the surgery, and both clinical and radiographic data will be collected at 4 months postoperative to assess the implants status. A radiographic follow-up will be done 1 year after the surgery. Peri-implant crevicular fluid levels of 3 known immunological markers for bone loss (MMP-8, sRANKL and OPG) will be measured at 1-, 3- and 16-weeks follow-ups. The findings from this study might allow clinicians to establish the ideal antibiotic regimen with minimal risk exposure to bacterial resistance.

Conditions

  • Dental Implants

Interventions

DRUG

Amoxicillin

Sponsors & Collaborators

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Robert Durand, DMD, MS · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851681 on ClinicalTrials.gov