The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success

Study Overview
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Brief Summary
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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).

Official Title
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The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success

Conditions
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Tooth Loss

Intervention / Treatment
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* Procedure: Dental implant placement
* Drug: Antibiotic prophylaxis
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tooth loss Exclusion Criteria: Systemic disease Lactation/pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylaxis<br>2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery | Procedure: Dental implant placement<br>* Insertion of not more than two dental implants at the same area<br>Drug: Antibiotic prophylaxis<br>* Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery<br>|
| Placebo Comparator: Placebo<br>placebo 1 hour prior to dental implant surgery | Procedure: Dental implant placement<br>* Insertion of not more than two dental implants at the same area<br>Other: Placebo<br>* Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline implant stability / osseointegration | Periotest M | Baseline | 
| 10th day implant stability / osseointegration | Periotest M | 10th day | 
| 1st month implant stability / osseointegration | Periotest M | 1st month | 
| Final implant stability / osseointegration | Periotest M | 3rd month | 
| Radiographic bone loss | The distance of the bone crest to the implant shoulder | 3rd month | 
| Early healing index (Wachtel et al) | Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5) | 10th day | 
| Early healing index (Wachtel et al) | Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5) | 1st month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation duration | Duration between the first incision and the last suture | Baseline | 
| Painkiller (0-3 days) | 500 mg paracetamol, the count of the painkillers the subject used | Baseline - 3rd day | 
| Painkiller (3-10 days) | 500 mg paracetamol, the count of the painkillers the subject used | 3rd day - 10th day | 
| Operation zone length | (mm) the crestal incision and vertical incision (if applied) length | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implants, Antibiotic Prophylaxis