NCT04937114

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 17, 2021

Last Update Submit

June 22, 2021

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

  • To assess primary wound closure

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

    Baseline to 21days

Secondary Outcomes (1)

  • To assess pain

    Baseline to 21days

Study Arms (2)

Flap will be approximated using conventional, simple continuous suturing with barbed sutures

EXPERIMENTAL

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

Flap will be approximated using conventional, simple continuous suturing with conventional sutures

ACTIVE COMPARATOR

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

Barbed suturePROCEDURE

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

Flap will be approximated using conventional, simple continuous suturing with barbed suturesFlap will be approximated using conventional, simple continuous suturing with conventional sutures

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Telangana, 509002, India

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 23, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)