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

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).

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: Dental implant placement; Drug: Antibiotic prophylaxis; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Yılmaz, PhD; Phone Number: +905337129952; Email: myilmaz@biruni.edu.tr
• Study Contact Backup: Name: Burcu Karaduman, PhD; Email: bkaraduman@biruni.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Biruni University
    • Contact: Mustafa YILMAZ, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Tooth loss

Exclusion Criteria:

• Systemic disease
• Lactation/pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Principal Investigator: Mustafa Yılmaz, PhD, Biruni University, assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dental Implants; Antibiotic Prophylaxis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: Implant prophylaxis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD will be shared
• IPD Sharing Time Frame: Starting one year after the publication
• IPD Sharing Access Criteria: All the collected data will be accessible to researchers conducting meta-analysis or examining the reliability of our study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No