The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

Study Overview
=================
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).

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.

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

Conditions
-----------------
Infection Control, Antibiotic Prophylaxis

Intervention / Treatment
-----------------
* Drug: Amoxicillin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin oral tablets<br>2 g amoxicillin tablets orally 1 hour before implant placement | Drug: Amoxicillin<br>* Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement<br>* Other names: Amoxicillin oral tablets;|
| Placebo Comparator: Placebo<br>Placebo tablets orally 1 hour before implant placement | Other: Placebo<br>* Placebo consisting of 4 tablets, orally 1 hour before implant placement<br>* Other names: Placebo oral tablets (for Amoxicillin);|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental implants, antibiotic prophylaxis