Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications

August 20, 2023 updated by: levent Cigerim, Yuzuncu Yıl University

Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery

Some undesirable complications such as pain, swelling, trismus, paresthesia, hematoma, infection and, albeit rare, fractures may occur after lower impacted wisdom tooth surgery. More effective wound closure methods with fewer complications have positive effects on postoperative recovery. Suturing is the most commonly used wound closure technique after lower impacted wisdom tooth surgery. Suturing, which is the last step of the operation, contributes to wound healing in order to reposition and stabilize the tissue components and to control bleeding. In our study, it was aimed to evaluate the efficacy of silk and polyester sutures used in wound closure techniques, which are frequently used in lower impacted wisdom teeth surgery.

Study Overview

Status

Completed

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

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

    • Tuşba
      • Van, Tuşba, Turkey, 65080
        • Van Yuzuncu Yil University, Faculty of Dentistry

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

18 years and older (Adult)

Accepts Healthy Volunteers

Yes

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Levent Ciğerim, Assoc.Prof., Van Yüzüncü Yil University

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)

April 16, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 20, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21.05.2020/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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