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

NCT05679973 | Completed

• 1 other identifier: 03.07.2019/11
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Impacted Third Molar Tooth

Keywords

Polybutester; Polypropylene; Pain; Edema; Trismus

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Polybutester

EXPERIMENTAL

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

Polypropylene

ACTIVE COMPARATOR

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

Interventions

Polybutester suture DEVICE

After third molar surgery this suture used for primary closure.

Polybutester

Polypropylene suture DEVICE

After third molar surgery this suture used for primary closure.

Polypropylene

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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,
• Post-operative alveolitis.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Edema; Trismus

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Levent Ciğerim, Assoc.Prof.

  Yuzuncu Yil University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: January 11, 2023
• Study Start: September 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)