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Completed

NCT Number: NCT03412305

The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Malmö university

Malmö, 20506, Sweden

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement

Other names: Amoxicillin oral tablets

Placebo

Other

Placebo consisting of 4 tablets, orally 1 hour before implant placement

Other names: Placebo oral tablets (for Amoxicillin)

Primary outcomes

  1. Implant failure

    Time frame: 3-6 months after implant placement

    Early implant mobility and/or infection, which requires the implant to be removed.

Secondary outcomes

  1. Postoperative infection

    Time frame: 7-14 days after implant placement

    Presence of swelling, redness, pus, pain and wound dehiscence

  2. Infection

    Time frame: 3-6 months after implant placement

    Presence of any type of infection such as abscess, fistula

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2021
First posted
Jan 26, 2018
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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