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

Not Applicable

Recruiting

• Conditions: Tooth Loss
• Interventions: Procedure: Dental implant placement; Other: Placebo; Drug: Antibiotic prophylaxis

• Registration Number: NCT04856319
• Lead Sponsor: Biruni University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Study Start: 2022-09-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Tooth loss

Exclusion Criteria

• Systemic disease
• Lactation/pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylaxis	Dental implant placement	2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
Placebo	Dental implant placement	placebo 1 hour prior to dental implant surgery
Placebo	Placebo	placebo 1 hour prior to dental implant surgery
Prophylaxis	Antibiotic prophylaxis	2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery

Primary Outcome Measures

Name	Time	Method
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
Radiographic bone loss	3rd month	The distance of the bone crest to the implant shoulder
Final implant stability / osseointegration	3rd month	Periotest M
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

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

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey