Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03412305
Other study ID # AB-IMP
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT03028129 - Prevention of Tuberculosis in Prisons Phase 4
Completed NCT05612542 - Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
Completed NCT03765645 - Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors N/A
Completed NCT03306290 - Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery N/A
Recruiting NCT03283878 - Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial Phase 4
Not yet recruiting NCT05438082 - Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG Phase 4
Recruiting NCT05654896 - Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma Phase 3
Recruiting NCT05609240 - Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery Phase 2
Withdrawn NCT04280237 - Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
Completed NCT02479503 - Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Completed NCT00818766 - Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy. N/A
Recruiting NCT05755789 - Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery Phase 3
Withdrawn NCT01880112 - Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery. Phase 4
Withdrawn NCT03982810 - The Role of Guideline-adherent Perioperative Antibiotic Administration and the Risk of Surgical Site Infections After Non-cardiac Surgery.
Recruiting NCT03269604 - Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria. N/A
Terminated NCT03386227 - Prophylactic Antibiotics Prior to Embryo Transfer (PAPET): RCT N/A
Completed NCT02809729 - Antibiotic Prophylaxis in Oncological Surgery of Breast N/A
Completed NCT03790254 - D Mannose for Prevention and Treatment of RUTIs
Recruiting NCT05519072 - Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Phase 4
Not yet recruiting NCT05813184 - Prenatal Antibiotics and Breast Milk / Neonatal IgA