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

NCT04620018 | Completed DMC

• 1 other identifier: 1399
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implant Failed

Keywords

dental implant; osseointegration; infection

Outcome Measures

Primary Outcomes (1)

• Infection incidence

  pain, redness of the area, and discharge around the fixture.

  3 months

Study Arms (3)

Pre and post op Antibiotic

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Pre-op antibiotic

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Post-op antibiotic

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

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

Also known as: GLAXOSMITHKLINE

Post-op antibiotic; Pre and post op Antibiotic; Pre-op antibiotic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

MeSH Terms

Conditions

Infections

Interventions

Amoxicillin; halofantrine

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Reza Tabrizi, DDS

  Shiraz University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: An independent investigator who was blind to participants (groups) evaluated all subjects
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shiraz university of medical sciences

Model Details: 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) .

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: September 30, 2016
• Primary Completion: February 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12.1.2020
• Access Criteria: Researchers who are eligible to access shahid beheshti university of medical sciences website