- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112366
Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth
October 26, 2023 updated by: Serap Keskin Tunc, Yuzuncu Yıl University
Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery.
In the 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 the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture.
The selected side was determined by a closed envelope procedure.
After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted.
Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus.
Wound healing was evaluated as good, acceptable and poor.
VAS (Visual Analog Scale) was used for pain assessment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Van, Turkey, 65100
- Serap Keskin Tunc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteers with bilateral fully impacted mandibular wisdom teeth
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The study group used tissue adhesive for wound closure after extraction of impacted wisdom teeth
In 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.
|
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.
Other Names:
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Placebo Comparator: Control group used silk sutures after extraction of impacted wisdom teeth
Bilateral 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial edema
Time Frame: 0-28 days
|
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.
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0-28 days
|
Wound healing
Time Frame: 0-28 days
|
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.
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0-28 days
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Visual Analog Scale
Time Frame: 0-28 days
|
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.
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0-28 days
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Mouth opening measurements
Time Frame: 0-28 days
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The distance between the incisals of the patient's central teeth at maximal mouth opening.
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0-28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
July 25, 2023
Study Registration Dates
First Submitted
October 17, 2023
First Submitted That Met QC Criteria
October 26, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YYU-04/05.18.2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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