Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery

November 18, 2020 updated by: RTabrizi, Shiraz University of Medical Sciences
Subjects who underwent a dental implant surgery were studied.Subjects randomly were aligned into three groups:In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days). The sign and symptom of infection were studied and the incidence of infection in each group was determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and underwent a dental implant surgery. Subjects were excluded from study enrollment if they had systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused study enrollment or failed to return for follow-up.

Subjects were randomly divided into three groups : In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) . An independent researcher made random allocation cards using computer-generated random. Then, allocated cases were placed in a sealed envelope. All subjects used 0.2% chlorhexidine mouthwash in the treatment period. All implants were placed with a two-stage protocol.

All subjects were followed up for 3 months to assess any infection signs and symptoms. Infection was diagnosed based on clinical findings such as pain, redness of the area, and discharge around the fixture.An independent dentist who was blind the study groups, evaluated all subjects.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have an edentulous area in the mandible or maxilla
  • underwent a dental implant surgery

Exclusion Criteria:

  • systemic diseases which affect bone metabolism
  • history of allergy to amoxicillin
  • refused study enrollment
  • failed to return for follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pre and post op Antibiotic
subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
Drug: Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other Names:
  • GLAXOSMITHKLINE
Active Comparator: Pre-op antibiotic
subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)
Drug: Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other Names:
  • GLAXOSMITHKLINE
Active Comparator: Post-op antibiotic
subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
Drug: Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other Names:
  • GLAXOSMITHKLINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection incidence
Time Frame: 3 months
pain, redness of the area, and discharge around the fixture.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Director: Reza Tabrizi, DDS, shiraz University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2016

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We can present the data of participant without individual identification.

IPD Sharing Time Frame

12.1.2020

IPD Sharing Access Criteria

Researchers who are eligible to access shahid beheshti university of medical sciences website

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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