The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Study Details
Study Description
Brief Summary
There is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. Current reports on antibiotic use are insufficient. Also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively.
This study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Prophylaxis 2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery |
Procedure: Dental implant placement
Insertion of not more than two dental implants at the same area
Drug: Antibiotic prophylaxis
Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
|
Placebo Comparator: Placebo placebo 1 hour prior to dental implant surgery |
Procedure: Dental implant placement
Insertion of not more than two dental implants at the same area
Other: Placebo
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
|
Outcome Measures
Primary Outcome Measures
- Baseline implant stability / osseointegration [Baseline]
Periotest M
- 10th day implant stability / osseointegration [10th day]
Periotest M
- 1st month implant stability / osseointegration [1st month]
Periotest M
- Final implant stability / osseointegration [3rd month]
Periotest M
- Radiographic bone loss [3rd month]
The distance of the bone crest to the implant shoulder
- Early healing index (Wachtel et al) [10th day]
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
- Early healing index (Wachtel et al) [1st month]
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Secondary Outcome Measures
- Operation duration [Baseline]
Duration between the first incision and the last suture
- Painkiller (0-3 days) [Baseline - 3rd day]
500 mg paracetamol, the count of the painkillers the subject used
- Painkiller (3-10 days) [3rd day - 10th day]
500 mg paracetamol, the count of the painkillers the subject used
- Operation zone length [Baseline]
(mm) the crestal incision and vertical incision (if applied) length
Eligibility Criteria
Criteria
Inclusion Criteria:
- Tooth loss
Exclusion Criteria:
-
Systemic disease
-
Lactation/pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Biruni University | Istanbul | Turkey |
Sponsors and Collaborators
- Biruni University
Investigators
- Principal Investigator: Mustafa Yılmaz, PhD, Biruni University, assistant professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Implant prophylaxis