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

NCT ID: NCT03659344

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-07-30

Brief Summary

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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

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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.

Conditions

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Infection, Surgical Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients were blind about kind of sutures which were used to close flaps.

Study Groups

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Vicryl plus

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

Group Type ACTIVE_COMPARATOR

Vicryl plus

Intervention Type DRUG

Using vicryl sutures which coated with triclosan (antibiotic)

vicryl

In this group, vicryl sutures were used to close flaps

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vicryl plus

Using vicryl sutures which coated with triclosan (antibiotic)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Need 3 dental implants at the posterior of the mandible

Exclusion Criteria

* Diabetic patients
* smoker
* poor oral hygiene
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Tabrizi

Associate professor of OMFS

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IR.SBMU.RIDS.REC.1395.336

Identifier Type: -

Identifier Source: org_study_id

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