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

NCT05534204 | Completed

• 1 other identifier: 21.05.2020/06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (5)

• 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).

  Postoperative1st day

• 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 2nd day

• 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 3rd day

• 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 5th day

• 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 7th day

Study Arms (2)

Silk suture

ACTIVE COMPARATOR

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

Procedure: Silk suture

Polyester suture

ACTIVE COMPARATOR

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

Procedure: Polyester suture

Interventions

Silk suture PROCEDURE

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.

Silk suture

Polyester suture PROCEDURE

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.

Polyester suture

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Study Officials

• Levent Ciğerim, Assoc.Prof.

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oral and Maxillofacial Surgery Department

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: September 9, 2022
• Study Start: April 16, 2020
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)