search
Back to results

Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study

Primary Purpose

Infection, Surgical Site

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vicryl plus
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Surgical Site focused on measuring sutures, Surgical Wound Infection, Polyglactin 910

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Need 3 dental implants at the posterior of the mandible

Exclusion Criteria:

  • Diabetic patients
  • smoker
  • poor oral hygiene

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Vicryl plus

    vicryl

    Arm Description

    In this group, vicryl plus(Triclosan coated) sutures were used to close flaps

    In this group, vicryl sutures were used to close flaps

    Outcomes

    Primary Outcome Measures

    The prevalence of post-operative infection
    The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.
    The prevalence of post-operative dehiscence
    The number of participants who had relatively or completely open wound

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2018
    Last Updated
    September 3, 2018
    Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03659344
    Brief Title
    Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study
    Official Title
    Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    February 1, 2018 (Actual)
    Study Completion Date
    July 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.
    Detailed Description
    Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson & Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson & Johnson Company, Sommerville, NJ) in group II. All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries. Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented. Patients were blind about what suture was used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Surgical Site
    Keywords
    sutures, Surgical Wound Infection, Polyglactin 910

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
    Masking
    Participant
    Masking Description
    Patients were blind about kind of sutures which were used to close flaps.
    Allocation
    Randomized
    Enrollment
    320 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vicryl plus
    Arm Type
    Active Comparator
    Arm Description
    In this group, vicryl plus(Triclosan coated) sutures were used to close flaps
    Arm Title
    vicryl
    Arm Type
    No Intervention
    Arm Description
    In this group, vicryl sutures were used to close flaps
    Intervention Type
    Drug
    Intervention Name(s)
    Vicryl plus
    Intervention Description
    Using vicryl sutures which coated with triclosan (antibiotic)
    Primary Outcome Measure Information:
    Title
    The prevalence of post-operative infection
    Description
    The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.
    Time Frame
    In one month
    Title
    The prevalence of post-operative dehiscence
    Description
    The number of participants who had relatively or completely open wound
    Time Frame
    In one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Need 3 dental implants at the posterior of the mandible Exclusion Criteria: Diabetic patients smoker poor oral hygiene

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study

    We'll reach out to this number within 24 hrs