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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04620018
Enrollment
450
Registered
2020-11-06
Start date
2016-09-30
Completion date
2020-09-01
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Failed

Keywords

dental implant, osseointegration, infection

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.

Interventions

DRUGAmoxicillin

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

Sponsors

Shahid Beheshti University of Medical Sciences
CollaboratorOTHER
Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

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) .

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Infection incidence3 monthspain, redness of the area, and discharge around the fixture.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026