Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery

Tooth Diseases Clinical Trial

Official title:

Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Pain, Edema and Trismus in Impacted Wisdom Dental Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06280014
• Other study ID #: YYU-09/15.12.2021
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tooth Diseases
• Tooth, Impacted

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