The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

August 19, 2021 updated by: Bengt Götrick, Malmö University

Effect of Antibiotic Prophylaxis in Dental Implant Surgery - a Multicenter Placebo-controlled Double-blinded Randomized Clinical Trial

The overall aim of the study is to investigate whether routine administration of antibiotic prophylaxis 1 hour prior to implant surgery may prevent postoperative infection and implant loss in healthy or substantially healthy patients (ASA Class 1 and Class 2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of bacteria resistant to antibiotics is increasing and there is a correlation between high consumption of antibiotics and high incidence of antibiotic resistance. It is therefore important to reduce the prescription of antibiotics. Antibiotics in dental care are used to treat oral infections as well as to prevent infections associated with surgical procedures. An example of the latter is antibiotic prophylaxis associated with dental implant surgery in order to reduce the risk of postoperative infection that can lead to loss of implant.The study will be conducted as a multicenter placebo-controlled randomized clinical trial. Eligible patients will be asked for participation and those who leave oral and written information will be included in the study. Patients included will be allocated to either active treatment (antibiotic prophylaxis) or placebo. Both clinicians and patients will be blinded to group affiliation. A total of 10 clinicians in 8 centers in the south of Sweden have agreed to participate and each clinicians will be allowed to use the implants and routines that they usually work with.

Specific aims of the study are to test the following hypotheses:

  1. There is no difference in proportion of patients with early implant losses in patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.
  2. There is no difference in proportion of patients with early infections between patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.
  3. There is no difference in infections (within 3-6 months postoperatively) between patients receiving 2 g of amoxicillin preoperatively and patients receiving identical placebo tablets.

If it appears that antibiotic prophylaxis does not lead to any risk reduction, this result may provide a basis for guidelines rejecting antibiotic prophylaxis in dental implant surgery.

Study Type

Interventional

Enrollment (Actual)

474

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20506
        • Malmo university

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Requirement for dental implant placement
  • Over 18 years of age

Exclusion Criteria:

  • Immunosuppressed or immunocompromised
  • Affected by not controlled diabetes
  • Serious or severe systemic disease (ASA classification > 2)
  • Previous radiotherapy to the head or neck area
  • Ongoing acute or chronic infection in the oral cavity
  • Ongoing treatment with antibiotics
  • Hypersensitivity to penicillin
  • Previous or ongoing treatment with bisphosphonates
  • In need of major bone augmentation
  • Planned direct loading or early loading (within 2 weeks) of the implant

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amoxicillin oral tablets
2 g amoxicillin tablets orally 1 hour before implant placement
Drug: Amoxicillin
Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement
Other Names:
  • Amoxicillin oral tablets
Placebo Comparator: Placebo
Placebo tablets orally 1 hour before implant placement
Other: Placebo
Placebo consisting of 4 tablets, orally 1 hour before implant placement
Other Names:
  • Placebo oral tablets (for Amoxicillin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant failure
Time Frame: 3-6 months after implant placement
Early implant mobility and/or infection, which requires the implant to be removed.
3-6 months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative infection
Time Frame: 7-14 days after implant placement
Presence of swelling, redness, pus, pain and wound dehiscence
7-14 days after implant placement
Infection
Time Frame: 3-6 months after implant placement
Presence of any type of infection such as abscess, fistula
3-6 months after implant placement

Collaborators and Investigators

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

Sponsor

Malmö University

Investigators

  • Principal Investigator: Bengt Götrick, Malmo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-IMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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