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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05679973
Other study ID # 03.07.2019/11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date September 1, 2020

Study information

Verified date December 2022
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 )


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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


Intervention

Device:
Polybutester suture
After third molar surgery this suture used for primary closure.
Polypropylene suture
After third molar surgery this suture used for primary closure.

Locations

Country Name City State
Turkey Van Yuzuncu Yil University, Faculty of Dentistry Van

Sponsors (1)

Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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