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Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery

NCT ID: NCT04620018

Last Updated: 2020-11-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-09-01

Brief Summary

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Subjects who underwent a dental implant surgery were studied.Subjects randomly were aligned into three groups:In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days). The sign and symptom of infection were studied and the incidence of infection in each group was determined.

Detailed Description

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Subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and underwent a dental implant surgery. Subjects were excluded from study enrollment if they had systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused study enrollment or failed to return for follow-up.

Subjects were randomly divided into three groups : In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) . An independent researcher made random allocation cards using computer-generated random. Then, allocated cases were placed in a sealed envelope. All subjects used 0.2% chlorhexidine mouthwash in the treatment period. All implants were placed with a two-stage protocol.

All subjects were followed up for 3 months to assess any infection signs and symptoms. Infection was diagnosed based on clinical findings such as pain, redness of the area, and discharge around the fixture.An independent dentist who was blind the study groups, evaluated all subjects.

Conditions

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Dental Implant Failed

Keywords

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dental implant osseointegration infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

subjects were aligned randomly into three groups.In group 1, subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) .
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
An independent investigator who was blind to participants (groups) evaluated all subjects

Study Groups

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Pre and post op Antibiotic

subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.

Pre-op antibiotic

subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.

Post-op antibiotic

subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.

Interventions

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Amoxicillin

Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.

Intervention Type DRUG

Other Intervention Names

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GLAXOSMITHKLINE

Eligibility Criteria

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Inclusion Criteria

* Have an edentulous area in the mandible or maxilla
* underwent a dental implant surgery

Exclusion Criteria

* systemic diseases which affect bone metabolism
* history of allergy to amoxicillin
* refused study enrollment
* failed to return for follow-up.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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RTabrizi

Shiraz university of medical sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reza Tabrizi, DDS

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Other Identifiers

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1399

Identifier Type: -

Identifier Source: org_study_id