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

Not Applicable

Completed

• Conditions: Dental Implant Failed
• Interventions: Drug: Amoxicillin

• Registration Number: NCT04620018
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09-30
• Primary Completion: 2020-02-01
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-op antibiotic	Amoxicillin	subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)
Post-op antibiotic	Amoxicillin	subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
Pre and post op Antibiotic	Amoxicillin	subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)

Primary Outcome Measures

Name	Time	Method
Infection incidence	3 months	pain, redness of the area, and discharge around the fixture.