Antibiotic Prophylaxis Clinical Trial
Official title:
Effect of Antibiotic Prophylaxis in Dental Implant Surgery - a Multicenter Placebo-controlled Double-blinded Randomized Clinical Trial
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 |
Verified date | August 2021 |
Source | Malmö University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Malmö university | Malmö |
Lead Sponsor | Collaborator |
---|---|
Malmö University |
Sweden,
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 |
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