Tooth Loss
Conditions
Keywords
Dental Implants, Antibiotic Prophylaxis
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).
Interventions
PROCEDUREDental implant placement
Insertion of not more than two dental implants at the same area
DRUGAntibiotic prophylaxis
Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
OTHERPlacebo
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The patients and the surgeon will be masked if antibiotics or placebo were used.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Tooth loss
Exclusion criteria
* Systemic disease * Lactation/pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Baseline implant stability / osseointegration | Baseline | Periotest M |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Operation duration | Baseline | Duration between the first incision and the last suture |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMustafa Yılmaz, PhD
Backup ContactBurcu Karaduman, PhD
Outcome results
None listed