An interventional study of Amoxicillin in Dental Implant Failed, sponsored by Shiraz University of Medical Sciences. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 450 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
Drug: Amoxicillin
subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)
Drug: Amoxicillin
subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)
Drug: Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Also known as: GLAXOSMITHKLINE
Infection incidence
pain, redness of the area, and discharge around the fixture.
Time frame: 3 months
No study locations are listed for this record.
Plan to share: Yes — We can present the data of participant without individual identification.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences