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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylaxis | Active Comparator | 2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery |
|
| Placebo | Placebo Comparator | placebo 1 hour prior to dental implant surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant placement | Procedure | Insertion of not more than two dental implants at the same area |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Yılmaz, PhD | Contact | +905337129952 | myilmaz@biruni.edu.tr | |
| Burcu Karaduman, PhD | Contact | bkaraduman@biruni.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Mustafa Yılmaz, PhD | Biruni University, assistant professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Recruiting | Istanbul | Turkey (Türkiye) |
All IPD will be shared
Starting one year after the publication
All the collected data will be accessible to researchers conducting meta-analysis or examining the reliability of our study
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
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The patients and the surgeon will be masked if antibiotics or placebo were used.
| Antibiotic prophylaxis | Drug | Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery |
|
| Placebo | Other | Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery |
|
| 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 |