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

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ClinicalTrials.gov Identifier: NCT04620018
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
RTabrizi, Shiraz University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Implant Failed Drug: Amoxicillin Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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) .
Masking: Single (Participant)
Masking Description: An independent investigator who was blind to participants (groups) evaluated all subjects
Primary Purpose: Prevention
Official Title: Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pre and post op Antibiotic
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 Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other Name: GLAXOSMITHKLINE
Active Comparator: Pre-op antibiotic
subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)
 Drug: Amoxicillin
Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
Other Name: GLAXOSMITHKLINE
Active Comparator: Post-op antibiotic
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.
Other Name: GLAXOSMITHKLINE


Outcome Measures
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Primary Outcome Measures :
  1. Infection incidence [ Time Frame: 3 months ]
    pain, redness of the area, and discharge around the fixture.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620018


Sponsors and Collaborators
Shiraz University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
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Study Director: Reza Tabrizi, DDS Shiraz University of Medical Sciences
More Information
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Responsible Party: RTabrizi, Shiraz university of medical sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04620018    
Other Study ID Numbers: 1399
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We can present the data of participant without individual identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 12.1.2020
Access Criteria: Researchers who are eligible to access shahid beheshti university of medical sciences website
URL: http://sbmu.ac.ir

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTabrizi, Shiraz University of Medical Sciences:
dental implant
osseointegration
infection
Additional relevant MeSH terms:
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Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents