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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03659344
Other study ID # IR.SBMU.RIDS.REC.1395.336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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