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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04856319
Other study ID # Implant prophylaxis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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