- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05534204
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, single-blind, split-mouth study was carried out on 30 patients who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery. Silk suture was used on one side of the patients and polyester suture was used on the other side. When the patients first applied to the clinic, their anamnesis was taken and panoramic images were taken after clinical evaluations were made.
Evaluations were made with preoperative face measurements (for evaluation of swelling), maximum mouth opening (for evaluation of trismus) and periodontal measurements for all patients. The mentioned measurements and evaluations were repeated on the 2nd and 7th postoperative days. In addition, postoperative pain was evaluated with the VAS scale.
The same surgical procedure was performed by the same surgeon for all patients. After local anesthesia (2ml of 80 mg Articaine hydrochloride + 0.02mg Epinephrine bitartrate) a 3-corner flap containing the vertical incision passing through the mesial of the number 7 was lifted, the bone removed under saline cooling and the teeth were separated when needed. Afterwards, the extraction sockets will be irrigated with saline to control bleeding, and the area is closed primarily with silk or polyester suture material.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tuşba
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Van, Tuşba, Turkey, 65080
- Van Yuzuncu Yil University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 18 years and over
- Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell & Gregory classification,
- Asymptomatic impacted teeth,
- Individuals who is coming to control and fill in the given and requested forms,
- Individuals with an operation time of 30 minutes or less
Exclusion Criteria:
- Systemic disease,
- Smoking,
- Pregnancy or breastfeeding,
- Allergy to the drugs to be used in the study,
- Using any additional medication that may affect the outcome of the study,
- Using medication until 2 weeks before the operations,
- Post-operative alveolitis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Silk suture
Silk suture is a multifilament suture, used for surgical sides closure.
|
Patients with bilateral impacted lower third molars will have operations for both sides.
On one side for primarily closure after operation silk suture will be used.
|
|
Active Comparator: Polyester suture
Polyester suture is a monofilament suture, used for surgical sides closure.
|
Patients with bilateral impacted lower third molars will have operations for both side.
On one side for primarily closure after operation polyester suture will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: Postoperative1st day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperative1st day
|
|
Postoperative Pain
Time Frame: Postoperative 2nd day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperative 2nd day
|
|
Postoperative Pain
Time Frame: Postoperative 3rd day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperative 3rd day
|
|
Postoperative Pain
Time Frame: Postoperative 5th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperative 5th day
|
|
Postoperative Pain
Time Frame: Postoperative 7th day
|
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
|
Postoperative 7th day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Levent Ciğerim, Assoc.Prof., Van Yüzüncü Yil University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.05.2020/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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