The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2021-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics

NCT02185209

Periodontal Diseases Periimplantitis

COMPLETED PHASE4

The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success

NCT04856319

Tooth Loss

UNKNOWN NA

The Effect of Preoperative Antibiotics on Peri-implant Healing

NCT04280406

Dental Implant Failed

UNKNOWN PHASE1

Preoperative Dose of Co-amoxiclav for Prevention of Postoperative Complications in Dentoalveolar Surgery

NCT03844776

Infection

UNKNOWN NA

Surgical Treatment of Peri-implantitis

NCT01857804

Peri-Implantitis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection Control Antibiotic Prophylaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The tablets corresponding to each patient is packed in a container by the manufacturer of the trial drug. Each drug container is labeled by a code number (1-1000) and the contents of the containers are distributed according to a randomization list with block size 6. Randomization is thus carried out by the manufacturer, independent of investigator and participating clinicians.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amoxicillin oral tablets

2 g amoxicillin tablets orally 1 hour before implant placement

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

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

Placebo

Placebo tablets orally 1 hour before implant placement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amoxicillin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Amoxicillin oral tablets Placebo oral tablets (for Amoxicillin)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No