CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Amoxicillindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01851681
NCT01851681Phase 1Completed

Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants: a Randomized Clinical Trial

Université de Montréal·interventional·Posted May 10, 2013·Updated May 4, 2017

In Brief

A Phase 1 clinical trial evaluating Amoxicillin for Dental Implants. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Implants
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2013
Enrollment StartJul 1, 2014
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.1 years ago

Interventions

Amoxicillindrug