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

Not Applicable

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Device: Polybutester suture; Device: Polypropylene suture

• Registration Number: NCT05679973
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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

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 Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-01
• Study First Submitted: 2022-02-16
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-24
• Last Update Submitted: 2022-12-24
• Study First Posted: 2023-01-11
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Polybutester	Polybutester suture	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.
Polypropylene	Polypropylene suture	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.

Primary Outcome Measures

Name	Time	Method
Trismus evaluation	Postoperative 7th day	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.
Edema evaluation	Postoperative 7th day	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.
Trismus Evaluation	Preoperative	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.
Pain Evaluation	Postoperative 7th day	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).
Edema evaluation using Facial measurement	Postoperative 2nd day	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.

Trial Locations

Locations (1)

Van Yuzuncu Yil University, Faculty of Dentistry; 🇹🇷 Van, Turkey