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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06280014
Other study ID # YYU-09/15.12.2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date September 25, 2023

Study information

Verified date February 2024
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated.


Description:

The aim of this study; to compare the effects of dexketoprofen and mefanamic acid on pain, edema and trismus after lower impacted wisdom teeth surgery. 60 impacted wisdom teeth in 30 healthy individuals who applied to Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery with an indication for extraction of impacted lower wisdom teeth were included in the study. 60 impacted wisdom teeth belonging to individuals were randomly divided into two groups (A and B). In a randomized, controlled, double-blind study, dexketoprofen (A) and mefanamic acid (B) were given to patients immediately after surgery. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days. For the evaluation of edema, the facial measurements of the patients before the operation were recorded and repeated on the 2nd and 7th postoperative days. Preoperative maximum mouth opening measurement for trismus assessment was repeated on the 2nd and 7th postoperative days and recorded.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 25, 2023
Est. primary completion date February 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Volunteers with bilateral fully impacted mandibular wisdom teeth Exclusion Criteria: - Patients were excluded from the study if they did not understand the clinical procedures of the study, - Had allergies or intolerance to any of the substances used in the study, - Patients on anticoagulant or psychiatric treatment, - Pregnant or breastfeeding, - Patients using oral contraceptiveswere, - Diabetic, - Patients with periodontal disease or active infection, - Poor oral hygiene

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery of impacted mandibular wisdom teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was given mefenamic acid as a medication.
Surgery of impacted mandibular wisdom teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. After extraction of impacted wisdom tooth, the patient was dexketoprofen as a medication.

Locations

Country Name City State
Turkey Serap Keskin Tunc 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 Mouth opening measurements The distance between the incisals of the patient's central teeth at maximal mouth opening. 0-28 days
Primary Facial edema Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction. 0-28 days
Primary Visual Analog Scale A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms. 0-28 days
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