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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Silk suture
Polyester suture
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impacted Third Molar Tooth

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Van Yuzuncu Yil University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Silk suture

Polyester suture

Arm Description

Silk suture is a multifilament suture, used for surgical sides closure.

Polyester suture is a monofilament suture, used for surgical sides closure.

Outcomes

Primary Outcome Measures

Postoperative Pain
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 Pain
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 Pain
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 Pain
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 Pain
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).

Secondary Outcome Measures

Full Information

First Posted
February 14, 2022
Last Updated
August 20, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05534204
Brief Title
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications
Official Title
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silk suture
Arm Type
Active Comparator
Arm Description
Silk suture is a multifilament suture, used for surgical sides closure.
Arm Title
Polyester suture
Arm Type
Active Comparator
Arm Description
Polyester suture is a monofilament suture, used for surgical sides closure.
Intervention Type
Procedure
Intervention Name(s)
Silk suture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Polyester suture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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).
Time Frame
Postoperative1st day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperative 2nd day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperative 3rd day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperative 5th day
Title
Postoperative Pain
Description
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).
Time Frame
Postoperative 7th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Ciğerim, Assoc.Prof.
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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