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Completed

NCT Number: NCT05679973

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.

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Key information

Conditions

Impacted Third Molar Tooth Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University, Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

About this study

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 )

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polybutester suture

Device

After third molar surgery this suture used for primary closure.

Polypropylene suture

Device

After third molar surgery this suture used for primary closure.

Primary outcomes

  1. Pain Evaluation

    Time frame: Postoperative 1st 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).

  2. Pain Evaluation

    Time frame: Postoperative 2nd 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).

  3. Pain Evaluation

    Time frame: Postoperative 3rd 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).

  4. Pain Evaluation

    Time frame: Postoperative 5th 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).

  5. Pain Evaluation

    Time frame: 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).

  6. Edema evaluation using Facial measurement

    Time frame: Preoperative

    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.

  7. Edema evaluation using Facial measurement

    Time frame: 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.

  8. Edema evaluation

    Time frame: 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.

  9. Trismus Evaluation

    Time frame: 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.

  10. Trismus evaluation

    Time frame: Postoperative 2nd 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.

  11. Trismus evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2023
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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