Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth
Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2023
CompletedFirst Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedNovember 1, 2023
October 1, 2023
8 months
October 17, 2023
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Mouth opening measurements
The distance between the incisals of the patient's central teeth at maximal mouth opening.
0-28 days
Facial edema
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
0-28 days
Wound healing
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
0-28 days
Visual Analog Scale
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
0-28 days
Study Arms (2)
The study group used tissue adhesive for wound closure after extraction of impacted wisdom teeth
EXPERIMENTALIn this study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as an experimental group.
Control group used silk sutures after extraction of impacted wisdom teeth
PLACEBO COMPARATORBilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and silk sutures were used for wound closure.
Interventions
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with saline and the wound edges were sealed with tissue adhesive containing cyanoacrylate.
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures.
Eligibility Criteria
You may qualify if:
- Volunteers with bilateral fully impacted mandibular wisdom teeth
You may not qualify if:
- Patients were excluded from the study if they did not understand the clinical procedures of the study,
- Had allergies or intolerance to any of the substances used in the study,
- Patients on anticoagulant or psychiatric treatment,
- Pregnant or breastfeeding,
- Patients using oral contraceptiveswere,
- Diabetic,
- Patients with periodontal disease or active infection,
- Poor oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Serap Keskin Tunc
Van, 65100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Serap Keskin Tunc
Study Record Dates
First Submitted
October 17, 2023
First Posted
November 1, 2023
Study Start
May 20, 2022
Primary Completion
January 20, 2023
Study Completion
July 25, 2023
Last Updated
November 1, 2023
Record last verified: 2023-10