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

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620018
• Other study ID #: 1399
• Status: Completed
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant Failed
• Infection

Intervention

Drug:
• Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection incidence	pain, redness of the area, and discharge around the fixture.	3 months