Comparison of Three Antibiotic Protocols in Prevention of... | NCT04620018

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

NCT04620018

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Nov 20, 2020Actual

Enrollment

450Actual

Phase

Not Applicable

Conditions

Dental Implant Failed

Interventions

Amoxicillin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2016Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Nov 2, 2020

First Submission Date that Met QC Criteria

Nov 2, 2020

First Posted Date

Nov 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2020

Last Update Posted Date

Nov 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RTabrizi, Shiraz university of medical sciences, Shiraz University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shiraz University of Medical SciencesOTHER

Collaborators

Name	Class
Shahid Beheshti University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre and post op Antibiotic	Active Comparator	subjects received prophylactic antibiotic orally (Amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)	Drug: Amoxicillin
Pre-op antibiotic	Active Comparator	subjects received only prophylactic antibiotic (Amoxicillin 2mg ,1 hour before surgery)	Drug: Amoxicillin
Post-op antibiotic	Active Comparator	subjects received post-surgical antibiotic (Amoxicillin 500 mg , q8h for five days)	Drug: Amoxicillin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amoxicillin	Drug	Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.	Post-op antibiotic Pre and post op Antibiotic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reza Tabrizi, DDS	Shiraz University of Medical Sciences	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We can present the data of participant without individual identification.

Types

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

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin
C023768	halofantrine

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided

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) .