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

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

Detailed Description
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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 )

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

Conditions
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Impacted Third Molar Tooth

Intervention / Treatment
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* Device: Polybutester suture
* Device: Polypropylene suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polybutester<br>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<br>* After third molar surgery this suture used for primary closure.<br>|
| Active Comparator: Polypropylene<br>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<br>* After third molar surgery this suture used for primary closure.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polybutester, Polypropylene, Pain, Edema, Trismus