NCT06280014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 19, 2024

Last Update Submit

February 19, 2024

Conditions

Keywords

impacted wisdom teethdexketoprofenmefenamic acid

Outcome Measures

Primary Outcomes (3)

  • Mouth opening measurements

    The distance between the incisals of the patient's central teeth at maximal mouth opening.

    0-28 days

  • 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

  • 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

Study Arms (2)

Mefenamic acid was used to see post operative effects after extraction of 3rd molar in study group

EXPERIMENTAL

In this study of 30 patients, 22 females and 8 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and mefenamic acid was used as a drug to see post operative effects after extraction of impacted 3rd molars in the study group.

Procedure: Surgery of impacted mandibular wisdom teeth

Dexketoprofen was used to see post operative effects after extraction of 3rd molar in control group

PLACEBO COMPARATOR

Bilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and dexketoprofen was used as a drug to see post operative effects.

Procedure: Surgery of impacted mandibular wisdom teeth

Interventions

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.

Also known as: Surgery of impacted molar teeth
Mefenamic acid was used to see post operative effects after extraction of 3rd molar in study group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers with bilateral fully impacted mandibular wisdom teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serap Keskin Tunc

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, ImpactedTooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Serap Keskin Tunc

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

January 20, 2022

Primary Completion

February 20, 2022

Study Completion

September 25, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations