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

Study Overview
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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.

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

Conditions
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Dental Implant Failed

Intervention / Treatment
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* Drug: Amoxicillin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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) .
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre and post op Antibiotic<br>subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) | Drug: Amoxicillin<br>* Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.<br>* Other names: GLAXOSMITHKLINE;|
| Active Comparator: Pre-op antibiotic<br>subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery) | Drug: Amoxicillin<br>* Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.<br>* Other names: GLAXOSMITHKLINE;|
| Active Comparator: Post-op antibiotic<br>subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days) | Drug: Amoxicillin<br>* Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.<br>* Other names: GLAXOSMITHKLINE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection incidence | pain, redness of the area, and discharge around the fixture. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, osseointegration, infection