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

NCT ID: NCT04856319

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The patients and the surgeon will be masked if antibiotics or placebo were used.

Study Groups

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Prophylaxis

2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery

Group Type ACTIVE_COMPARATOR

Dental implant placement

Intervention Type PROCEDURE

Insertion of not more than two dental implants at the same area

Antibiotic prophylaxis

Intervention Type DRUG

Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery

Placebo

placebo 1 hour prior to dental implant surgery

Group Type PLACEBO_COMPARATOR

Dental implant placement

Intervention Type PROCEDURE

Insertion of not more than two dental implants at the same area

Placebo

Intervention Type OTHER

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

Interventions

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Dental implant placement

Insertion of not more than two dental implants at the same area

Intervention Type PROCEDURE

Antibiotic prophylaxis

Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Tooth loss

Exclusion Criteria

* Systemic disease
* Lactation/pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa YILMAZ

Assist Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Yılmaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Biruni University, assistant professor

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mustafa Yılmaz, PhD

Role: CONTACT

+905337129952

Burcu Karaduman, PhD

Role: CONTACT

Facility Contacts

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Mustafa YILMAZ, PhD

Role: primary

Other Identifiers

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Implant prophylaxis

Identifier Type: -

Identifier Source: org_study_id

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