Back to resultsEfficacy 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
About this trial
This is an interventional prevention trial for Infection, Surgical Site focused on measuring sutures, Surgical Wound Infection, Polyglactin 910
Eligibility Criteria
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
NCT ID
NCT03659344
First Posted
August 31, 2018
Last Updated
September 3, 2018
Sponsor
Shiraz University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
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
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