The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

Antibiotic Prophylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412305
• Other study ID #: AB-IMP
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 10, 2021

Study information

• Verified date: August 2021
• Source: Malmö University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: August 10, 2021
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Infection Control

Intervention

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

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

Locations

Country	Name	City	State
Sweden	Malmö university	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Malmö University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant failure	Early implant mobility and/or infection, which requires the implant to be removed.	3-6 months after implant placement
Secondary	Postoperative infection	Presence of swelling, redness, pus, pain and wound dehiscence	7-14 days after implant placement
Secondary	Infection	Presence of any type of infection such as abscess, fistula	3-6 months after implant placement