Wound HealNCT06020157
Comparison of Simple and Continuous Suture Techniques in Oral Surgery
A study testing Simple Suture Technique and Continuous Suture Technique in people with Wound Heal, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Simple Suture Technique and Continuous Suture Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2023to 27 Feb 2024
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Needing full arch alveoplasty
- No smoking
Who cannot join
- Uncontrolled systemic condition
- Not participating in control appointments
- Complications about wound healing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Dentistry Faculty
Konya, Selçuklu
About this study
Official title: Comparison of Simple and Continuous Suture Techniques in Oral Surgery Regarding Wound Healing, a Split-Mouth Clinical Trial
The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique.
It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.
- Conditions
- Wound Heal
- Being tested
- Simple Suture Technique, Continuous Suture Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Suture TechniqueOther
The half of the full arch flap will be closed by the simple suture technique.
Continuous Suture TechniqueOther
The half of the full arch flap will be closed by the continuous suture technique.
| Study group | Role | What they receive |
|---|---|---|
| Simple Suture Group | Experimental | Not described Receives: Other: Simple Suture Technique |
| Continuous Suture Group | Experimental | Not described Receives: Other: Continuous Suture Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Wound Healing Score-1
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Measured: Day 1
Early Wound Healing Score-3
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Measured: Day 3
Early Wound Healing Score-7
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Measured: Day 7
Suturing Time
The time between start and end of suture
Measured: 1 minutes after ending suture
Pain at Suture Removal
VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.
Measured: Day 7
Suture Removal Difficulty
VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start5 Oct 2023
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
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.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Şeyma Koyuncu, Principal investigator, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020157
- Sponsor's protocol ID
- Selcuk003
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simple and Continuous Suture Techniques in Oral Surgery Regarding Wound Healing, a Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT06020157
- Acronym / sponsor ID
- Selcuk003
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 31 Aug 2023 (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 study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique.
It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Suture Group | Experimental | Other: Simple Suture Technique |
| Continuous Suture Group | Experimental | Other: Continuous Suture Technique |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Needing full arch alveoplasty
- No smoking
Key exclusion criteria (3 listed)
- Uncontrolled systemic condition
- Not participating in control appointments
- Complications about wound healing
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 |
|---|---|---|
| Simple Suture TechniqueThe half of the full arch flap will be closed by the simple suture technique. | Other | Simple Suture Group |
| Continuous Suture TechniqueThe half of the full arch flap will be closed by the continuous suture technique. | Other | Continuous Suture Group |
Primary outcome
Early Wound Healing Score-1
Time frame: Day 1
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Early Wound Healing Score-3
Time frame: Day 3
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Early Wound Healing Score-7
Time frame: Day 7
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Suturing Time
Time frame: 1 minutes after ending suture
The time between start and end of suture
Pain at Suture Removal
Time frame: Day 7
VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.
Suture Removal Difficulty
Time frame: Day 7
VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Şeyma Koyuncu principal investigator
Selcuk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Suture Technique and Continuous Suture Technique in people with Wound Heal, run by Selcuk University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Wound Healing Score-1 (time frame: Day 1). The study lists 6 primary outcomes in all. 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 28 Feb 2024.