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Status unknownNCT04937114Updated Jun 23, 2021

Unidirectional Barbed Sutures in Mucogingival Procedures

An interventional study of Barbed suture in Wound Heal, sponsored by SVS Institute of Dental Sciences. Status unknown at 1 site in India. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by SVS Institute of Dental Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Wound Heal
03

In context

Lead sponsor

SVS Institute of Dental Sciences is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Medically compromised patients.
  • Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
  • Smokers
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
12 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureBarbed 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

06

What researchers measure

Primary outcomes

  1. To assess primary wound closure

    Primary wound closure and early wound healing by EHS at 7days,14days,21days

    Time frame: Baseline to 21days

Secondary outcomes

  1. To assess pain

    Pain by Visual Analogous Scale immediately

    Time frame: Baseline to 21days

07

Study locations

1 of 1 sites recruiting
  • SVS Institute of Dental Sciences, Mahabubnagar
    Hyderabad, Telangana 509002, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04937114
Lead sponsor
SVS Institute of Dental Sciences
Responsible party
Dr R Viswa Chandra (Primary Investigator, SVS Institute of Dental Sciences) — Principal investigator
First posted
Jun 23, 2021
Start date
Aug 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jun 23, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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