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Lornoxicam Versus Etodolac After Third Molar Surgery

Primary Purpose

Pain, Acute, Edema, Trismus

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Lornoxicam 8 Mg Oral Tablet
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zülfikar Karabıyık

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Etodolac

Lornoxicam

Arm Description

Etodolac, 400 mg tid per a day for four days

Lornoxicam, 8 mg twice per day for four days

Outcomes

Primary Outcome Measures

Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Edema after wisdom tooth extraction
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Trismus after wisdom tooth extraction
Trismus lower third molar removal, trismus was evaluated by using caliper

Secondary Outcome Measures

Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Edema after wisdom tooth extraction
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Trismus after wisdom tooth extraction
Trismus lower third molar removal, trismus was evaluated by using caliper

Full Information

First Posted
October 31, 2022
Last Updated
December 23, 2022
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05679453
Brief Title
Lornoxicam Versus Etodolac After Third Molar Surgery
Official Title
Comparison of Lornoxicam and Etodolac on Edema, Trismus and Pain After Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
September 25, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema and trismus following lower third molar extraction
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Edema, Trismus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etodolac
Arm Type
Active Comparator
Arm Description
Etodolac, 400 mg tid per a day for four days
Arm Title
Lornoxicam
Arm Type
Active Comparator
Arm Description
Lornoxicam, 8 mg twice per day for four days
Intervention Type
Drug
Intervention Name(s)
Lornoxicam 8 Mg Oral Tablet
Other Intervention Name(s)
Etodolac
Intervention Description
Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug
Primary Outcome Measure Information:
Title
Pain after wisdom tooth extraction
Description
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Time Frame
2 th hours
Title
Edema after wisdom tooth extraction
Description
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Time Frame
48 th hours
Title
Trismus after wisdom tooth extraction
Description
Trismus lower third molar removal, trismus was evaluated by using caliper
Time Frame
48 th hours,
Secondary Outcome Measure Information:
Title
Pain after wisdom tooth extraction
Description
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Time Frame
6 th hours
Title
Pain after wisdom tooth extraction
Description
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Time Frame
12 th hours
Title
Pain after wisdom tooth extraction
Description
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Time Frame
24 th hours
Title
Pain after wisdom tooth extraction
Description
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Time Frame
48 th hours
Title
Edema after wisdom tooth extraction
Description
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Time Frame
168 th hours
Title
Trismus after wisdom tooth extraction
Description
Trismus lower third molar removal, trismus was evaluated by using caliper
Time Frame
168 th hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zülfikar Karabıyık
City
Kutahya
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

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Lornoxicam Versus Etodolac After Third Molar Surgery

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