Back to resultsWound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery
Primary Purpose
Wound Heal
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Simple Suture Technique
Continuous Suture Technique
Sponsored by
About this trial
This is an interventional treatment trial for Wound Heal
Eligibility Criteria
Inclusion Criteria: Needing full arch alveoplasty No smoking Exclusion Criteria: Uncontrolled systemic condition Not participating in control appointments Complications about wound healing
Sites / Locations
- Selcuk University, Dentistry FacultyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Simple Suture Group
Continuous Suture Group
Arm Description
Outcomes
Primary Outcome Measures
Laundry Healing Index-1
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
Laundry Healing Index-3
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
Laundry Healing Index-7
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
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)
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)
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)
Suturing Time
The time between start and end of suture
Knot Looseness
Measure loosening of the suture material
Pain at Suture Removal
VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.
Suture Removal Difficulty
VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06020157
Brief Title
Wound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery
Official Title
Wound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is aimed to compare two different suture techniques in terms of wound healing. In this research, which is designed as an observational 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simple Suture Group
Arm Type
Experimental
Arm Title
Continuous Suture Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Simple Suture Technique
Intervention Description
The half of the full arch flap will be closed by the simple suture technique.
Intervention Type
Other
Intervention Name(s)
Continuous Suture Technique
Intervention Description
The half of the full arch flap will be closed by the continuous suture technique.
Primary Outcome Measure Information:
Title
Laundry Healing Index-1
Description
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
Time Frame
Day 1
Title
Laundry Healing Index-3
Description
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
Time Frame
Day 3
Title
Laundry Healing Index-7
Description
Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
Time Frame
Day 7
Title
Early Wound Healing Score-1
Description
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Time Frame
Day 1
Title
Early Wound Healing Score-3
Description
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Time Frame
Day 3
Title
Early Wound Healing Score-7
Description
Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
Time Frame
Day 7
Title
Suturing Time
Description
The time between start and end of suture
Time Frame
1 minutes after ending suture
Title
Knot Looseness
Description
Measure loosening of the suture material
Time Frame
Day 7
Title
Pain at Suture Removal
Description
VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.
Time Frame
Day 7
Title
Suture Removal Difficulty
Description
VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Needing full arch alveoplasty
No smoking
Exclusion Criteria:
Uncontrolled systemic condition
Not participating in control appointments
Complications about wound healing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gökhan Gürses
Phone
+905052595359
Email
gokhangurses.akademik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şeyma Koyuncu
Organizational Affiliation
Selcuk University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University, Dentistry Faculty
City
Konya
State/Province
Selçuklu
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gökhan Gürses
Phone
+905052595359
Email
gokhangurses.akademik@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Wound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery
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