Wound HealNCT04937114
Unidirectional Barbed Sutures in Mucogingival Procedures
A study testing Barbed suture in people with Wound Heal, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
The aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Barbed suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva.
Who cannot join
- Medically compromised patients.
- Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
- Smokers
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Telangana, 509002
Rampalli V Chandra, MDS; DNB, 9908183071, viswachandra@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Wound Heal
- Being tested
- Barbed suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed sutureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess primary wound closure
Primary wound closure and early wound healing by EHS at 7days,14days,21days
Measured: Baseline to 21days
Secondary outcomes (1)
To assess pain
Pain by Visual Analogous Scale immediately
Measured: Baseline to 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937114
- Sponsor's protocol ID
- SVSIDS/PERIO/5/2020
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Unidirectional Barbed Sutures on Various Outcomes in Mucogingival Procedures
- ClinicalTrials.gov ID
- NCT04937114
- Acronym / sponsor ID
- SVSIDS/PERIO/5/2020
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flap will be approximated using conventional, simple continuous suturing with barbed sutures | Experimental | Procedure: Barbed sutureAfter 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. |
| Flap will be approximated using conventional, simple continuous suturing with conventional sutures | Active comparator | Procedure: Barbed sutureAfter 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva.
Key exclusion criteria (3 listed)
- Medically compromised patients.
- Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed sutureExperimental: 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 | Procedure or surgery | Flap will be approximated using conventional, simple continuous suturing with barbed sutures, Flap will be approximated using conventional, simple continuous suturing with conventional sutures |
Primary outcome
To assess primary wound closure
Time frame: Baseline to 21days
Primary wound closure and early wound healing by EHS at 7days,14days,21days
1 secondary outcome
To assess pain
Time frame: Baseline to 21days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed suture in people with Wound Heal, run by SVS Institute of Dental Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess primary wound closure (time frame: Baseline to 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.