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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856319
• Other study ID #: Implant prophylaxis
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Biruni University
• Contact: Mustafa Yilmaz, PhD
• Phone: +905337129952
• Email: myilmaz[@]biruni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tooth loss

Exclusion Criteria:

• Systemic disease

• Lactation/pregnancy

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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

Other:
• Placebo
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline implant stability / osseointegration	Periotest M	Baseline
Primary	10th day implant stability / osseointegration	Periotest M	10th day
Primary	1st month implant stability / osseointegration	Periotest M	1st month
Primary	Final implant stability / osseointegration	Periotest M	3rd month
Primary	Radiographic bone loss	The distance of the bone crest to the implant shoulder	3rd month
Primary	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
Primary	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	Operation duration	Duration between the first incision and the last suture	Baseline
Secondary	Painkiller (0-3 days)	500 mg paracetamol, the count of the painkillers the subject used	Baseline - 3rd day
Secondary	Painkiller (3-10 days)	500 mg paracetamol, the count of the painkillers the subject used	3rd day - 10th day
Secondary	Operation zone length	(mm) the crestal incision and vertical incision (if applied) length	Baseline