An interventional study of Dental implant placement and Antibiotic prophylaxis in Tooth Loss, sponsored by Biruni University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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).
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
Procedure: Dental implant placement · Drug: Antibiotic prophylaxis
placebo 1 hour prior to dental implant surgery
Procedure: Dental implant placement · Other: Placebo
Insertion of not more than two dental implants at the same area
Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
Baseline implant stability / osseointegration
Periotest M
Time frame: Baseline
10th day implant stability / osseointegration
Periotest M
Time frame: 10th day
1st month implant stability / osseointegration
Periotest M
Time frame: 1st month
Final implant stability / osseointegration
Periotest M
Time frame: 3rd month
Radiographic bone loss
The distance of the bone crest to the implant shoulder
Time frame: 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)
Time frame: 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)
Time frame: 1st month
Operation duration
Duration between the first incision and the last suture
Time frame: Baseline
Painkiller (0-3 days)
500 mg paracetamol, the count of the painkillers the subject used
Time frame: Baseline - 3rd day
Painkiller (3-10 days)
500 mg paracetamol, the count of the painkillers the subject used
Time frame: 3rd day - 10th day
Operation zone length
(mm) the crestal incision and vertical incision (if applied) length
Time frame: Baseline
Plan to share: Yes — All IPD will be shared
Supporting information: Study protocol
Time frame: Starting one year after the publication
Access criteria: All the collected data will be accessible to researchers conducting meta-analysis or examining the reliability of our study
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Sep 2023, 12 months after the start.
Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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