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

Infection, Surgical Site Clinical Trial

Official title:

Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659344
• Other study ID #: IR.SBMU.RIDS.REC.1395.336
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2018
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: July 30, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Need 3 dental implants at the posterior of the mandible

Exclusion Criteria:

• Diabetic patients

• smoker

• poor oral hygiene

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection, Surgical Site
• Surgical Wound Infection

Intervention

Drug:
• Vicryl plus
Using vicryl sutures which coated with triclosan (antibiotic)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In one month
Primary	The prevalence of post-operative dehiscence	The number of participants who had relatively or completely open wound	In one month