The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

Sponsor

Malmö University (Other)

Overall Status

Completed

CT.gov ID

NCT03412305

Collaborator

(none)

474

Enrollment

Location

Arms

91.3

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Infection Control Antibiotic Prophylaxis	Drug: Amoxicillin Other: Placebo	Phase 4

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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

474 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, placebo-controlled trialRandomized, placebo-controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Aug 10, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Implant failure [3-6 months after implant placement]
Early implant mobility and/or infection, which requires the implant to be removed.

Secondary Outcome Measures

Postoperative infection [7-14 days after implant placement]
Presence of swelling, redness, pus, pain and wound dehiscence
Infection [3-6 months after implant placement]
Presence of any type of infection such as abscess, fistula

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malmö university	Malmö		Sweden	20506

Sponsors and Collaborators

Malmö University

Investigators

Principal Investigator: Bengt Götrick, Malmö University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bengt Götrick, associate professor, Malmö University

ClinicalTrials.gov Identifier:

NCT03412305

Other Study ID Numbers:

AB-IMP

First Posted:

Jan 26, 2018

Last Update Posted:

Aug 25, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bengt Götrick, associate professor, Malmö University

Dental implants, antibiotic prophylaxis

Additional relevant MeSH terms:

Amoxicillin

Study Results

No Results Posted as of Aug 25, 2021