Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery

This study aimed to evaluate the efficacy of polybutester sutures on postoperative complications in lower impacted third molar surgery.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Device: Polybutester suture; Device: Polypropylene suture

Detailed Description

After extraction of the bilateral lower third molars (35 patients), two different types of sutures were used on each side. Group 1( Polybutester suture) , group 2 (Polypropylene suture). Measurements to evaluate edema, trismus, and pain (using the VAS scale) had been taken pre-procedure and post-procedure( 2nd and 7th day )

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any medication until 2 weeks before the operations,
• Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell & Gregory classification,
• Asymptomatic impacted teeth.
• Coming to control and fill in the given and requested forms,
• Regularly use the given drugs

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,
• Post-operative alveolitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polybutester; Polybutester suture is a copolymer of polyglycol terephthalate and polybutylene terephthalate. It is a synthetic, non-resorbable, monofilament suture material. Polybutester is stronger than other monofilaments. Suture memory is poor and packaging does not retain its shape. Therefore, this suture is easier to work with and the knot security is higher. Polybutester suture adapts better to tensile strength than other synthetic sutures. This suture adapts to the increasing wound edema and returns to its original shape when the edema subsides. Also, this suture reduces the risk of hypertrophic scar formation due to its ability to adapt to the edema and changing configuration of a healing wound. It produces better cosmetic results.	Device: Polybutester suture; After third molar surgery this suture used for primary closure.
Active Comparator: Polypropylene; Polypropylene, used as suture material, is formed by bringing isotactic stereoisomers of a linear hydrocarbon crystalline polymer into sterile monofilament form. Polymer polypropylene is a non-resorbable, synthetic, monofilament suture. It has high compressive strength and low tissue reactivity. It is resistant to infection formation. In general, the ability to close and protect the wound is good. The suture memory is high, therefore it is difficult to use and the knot security is less than other sutures. Allergic reaction due to polypropylene sutures is very rare.	Device: Polypropylene suture; After third molar surgery this suture used for primary closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Evaluation	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 1st day
Pain Evaluation	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 2nd day
Pain Evaluation	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 3rd day
Pain Evaluation	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 5th day
Pain Evaluation	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 7th day
Edema evaluation using Facial measurement	The distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.	Preoperative
Edema evaluation using Facial measurement	Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.	Postoperative 2nd day
Edema evaluation	Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.	Postoperative 7th day
Trismus Evaluation	Preoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which were measured with a caliper.	Preoperative
Trismus evaluation	Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 2nd day
Trismus evaluation	Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 7th day

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Director: Levent Ciğerim, Assoc.Prof., Van Yüzüncü Yil University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: December 24, 2022
• First Posted (Estimate): January 11, 2023

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Edema; Polypropylene; Trismus; Polybutester
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Postoperative Complications; Tooth, Impacted
• Other Study ID Numbers: 03.07.2019/11

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