NCT05679453

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

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

July 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

October 31, 2022

Last Update Submit

December 23, 2022

Conditions

Pain, AcuteEdemaTrismus

Outcome Measures

Primary Outcomes (3)

  • Pain after wisdom tooth extraction

    Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)

    2 th hours

  • Edema after wisdom tooth extraction

    Edema lower third molar removal, Edema was evaluated by using reference line on the face

    48 th hours

  • Trismus after wisdom tooth extraction

    Trismus lower third molar removal, trismus was evaluated by using caliper

    48 th hours,

Secondary Outcomes (6)

  • Pain after wisdom tooth extraction

    6 th hours

  • Pain after wisdom tooth extraction

    12 th hours

  • Pain after wisdom tooth extraction

    24 th hours

  • Pain after wisdom tooth extraction

    48 th hours

  • Edema after wisdom tooth extraction

    168 th hours

  • +1 more secondary outcomes

Study Arms (2)

Etodolac

ACTIVE COMPARATOR

Etodolac, 400 mg tid per a day for four days

Drug: Lornoxicam 8 Mg Oral Tablet

Lornoxicam

ACTIVE COMPARATOR

Lornoxicam, 8 mg twice per day for four days

Drug: Lornoxicam 8 Mg Oral Tablet

Interventions

Lornoxicam 8 Mg Oral TabletDRUG

Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug

Also known as: Etodolac
EtodolacLornoxicam

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Bilateral mesioangular impacted lower third molar
  • Asymptomatic Third Molar (No history of infection)
  • Systemically Healthy Person
  • Person Between aged 18-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zülfikar Karabıyık

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute PainEdemaTrismus

Interventions

lornoxicamTabletsEtodolac

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsIndoleacetic AcidsAcids, HeterocyclicHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 31, 2022

First Posted

January 11, 2023

Study Start

July 20, 2022

Primary Completion

September 25, 2022

Study Completion

September 29, 2022

Last Updated

January 11, 2023

Record last verified: 2022-12

Locations

TU(1)