Unidirectional Barbed Sutures in Mucogingival Procedures

June 22, 2021 updated by: Dr R Viswa Chandra, SVS Institute of Dental Sciences

Efficacy of Unidirectional Barbed Sutures on Various Outcomes in Mucogingival Procedures

The aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Experimental: Main treatment group, flap will be approximated using conventional, simple continuous suturing with barbed sutures.

Comparator: In patients allocated to control group, flap will be approximated using conventional, simple continuous suturing with conventional sutures.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 509002
        • Recruiting
        • SVS Institute of Dental Sciences, Mahabubnagar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva.

Exclusion Criteria:

  • Medically compromised patients.
  • Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
  • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flap will be approximated using conventional, simple continuous suturing with barbed sutures
After administration of adequate amount of local anesthesia, planned muco-gingival surgery will be performed and flap will be approximated using conventional, simple continuous suturing with unidirectional barbed sutures.
Procedure: Barbed suture
Experimental: Wound will be closed using unidirectional barbed sutures in muco-gingival surgeries Active Comparator: Wound will be closed using conventional sutures in muco-gingival surgeries
Active Comparator: Flap will be approximated using conventional, simple continuous suturing with conventional sutures
After administration of adequate amount of local anesthesia, planned muco-gingival surgery will be performed and flap will be approximated using conventional, simple continuous suturing with conventional sutures.
Procedure: Barbed suture
Experimental: Wound will be closed using unidirectional barbed sutures in muco-gingival surgeries Active Comparator: Wound will be closed using conventional sutures in muco-gingival surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess primary wound closure
Time Frame: Baseline to 21days
Primary wound closure and early wound healing by EHS at 7days,14days,21days
Baseline to 21days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess pain
Time Frame: Baseline to 21days
Pain by Visual Analogous Scale immediately
Baseline to 21days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SVS Institute of Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SVSIDS/PERIO/5/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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