- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679453
Lornoxicam Versus Etodolac After Third Molar Surgery
December 23, 2022 updated by: Zulfikar Karabiyik, Kutahya Health Sciences University
Comparison of Lornoxicam and Etodolac on Edema, Trismus and Pain After Third Molar Surgery
Our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema and trismus following lower third molar extraction
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
20 patients included in study (4 male, 16 female).
Lornoxicam and etodolac was given following lower third molar extraction.
Pain was evaluated 2., 6., 12., 24., and 48.
hours using VAS.
Edema was evaluated by measuring tragus-labial commissure, angulus- lateral canthus of eye and angulus mandible-labial commissure.
Trismus was evaluated measuring mouth opening by caliper.
Edema and Trismus was evaluated by 48. and 168.
hours
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kutahya, Turkey, 43000
- Zülfikar Karabıyık
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bilateral mesioangular impacted lower third molar
- Asymptomatic Third Molar (No history of infection)
- Systemically Healthy Person
- Person Between aged 18-30
Exclusion Criteria:
- People who are pregnant and lactation process
- People who had any systemic disease
- People who are gastrointestinal problems
- People who are sensitive to drugs used in study
- Lower Third Molar associated with cysts and infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Etodolac
Etodolac, 400 mg tid per a day for four days
|
Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug
Other Names:
|
|
Active Comparator: Lornoxicam
Lornoxicam, 8 mg twice per day for four days
|
Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain after wisdom tooth extraction
Time Frame: 2 th hours
|
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
|
2 th hours
|
|
Edema after wisdom tooth extraction
Time Frame: 48 th hours
|
Edema lower third molar removal, Edema was evaluated by using reference line on the face
|
48 th hours
|
|
Trismus after wisdom tooth extraction
Time Frame: 48 th hours,
|
Trismus lower third molar removal, trismus was evaluated by using caliper
|
48 th hours,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain after wisdom tooth extraction
Time Frame: 6 th hours
|
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
|
6 th hours
|
|
Pain after wisdom tooth extraction
Time Frame: 12 th hours
|
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
|
12 th hours
|
|
Pain after wisdom tooth extraction
Time Frame: 24 th hours
|
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
|
24 th hours
|
|
Pain after wisdom tooth extraction
Time Frame: 48 th hours
|
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
|
48 th hours
|
|
Edema after wisdom tooth extraction
Time Frame: 168 th hours
|
Edema lower third molar removal, Edema was evaluated by using reference line on the face
|
168 th hours
|
|
Trismus after wisdom tooth extraction
Time Frame: 168 th hours
|
Trismus lower third molar removal, trismus was evaluated by using caliper
|
168 th hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2022
Primary Completion (Actual)
September 25, 2022
Study Completion (Actual)
September 29, 2022
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
December 23, 2022
First Posted (Estimate)
January 11, 2023
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
December 23, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Manifestations
- Spasm
- Acute Pain
- Trismus
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etodolac
- Lornoxicam
Other Study ID Numbers
- 10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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