Pain, AcutePhase 4NCT05679453
Lornoxicam Versus Etodolac After Third Molar Surgery
A Phase 4 study testing Lornoxicam 8 Mg Oral Tablet in people with Pain, Acute and Edema, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema and trismus following lower third molar extraction Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Edema, Trismus
- What is being tested?
- Lornoxicam 8 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2022to 29 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bilateral mesioangular impacted lower third molar
- Asymptomatic Third Molar (No history of infection)
- Systemically Healthy Person
- Person Between aged 18-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Pain, Acute, Edema, Trismus
- Being tested
- Lornoxicam 8 Mg Oral Tablet
- Medical subject headings
- Acute Pain, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lornoxicam 8 Mg Oral TabletDrug
Also called Etodolac
Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug
| Study group | Role | What they receive |
|---|---|---|
| Etodolac | Active comparator | Etodolac, 400 mg tid per a day for four days Receives: Drug: Lornoxicam 8 Mg Oral Tablet |
| Lornoxicam | Active comparator | Lornoxicam, 8 mg twice per day for four days Receives: Drug: Lornoxicam 8 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Measured: 2 th hours
Edema after wisdom tooth extraction
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Measured: 48 th hours
Trismus after wisdom tooth extraction
Trismus lower third molar removal, trismus was evaluated by using caliper
Measured: 48 th hours,
Secondary outcomes (6)
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Measured: 6 th hours
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Measured: 12 th hours
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Measured: 24 th hours
Pain after wisdom tooth extraction
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
Measured: 48 th hours
Edema after wisdom tooth extraction
Edema lower third molar removal, Edema was evaluated by using reference line on the face
Measured: 168 th hours
Trismus after wisdom tooth extraction
Trismus lower third molar removal, trismus was evaluated by using caliper
Measured: 168 th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start20 Jul 2022
- Primary completion25 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zulfikar Karabiyik, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679453
- Sponsor's protocol ID
- 10
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lornoxicam and Etodolac on Edema, Trismus and Pain After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05679453
- Acronym / sponsor ID
- 10
- Conditions
- Pain, Acute, Edema, Trismus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etodolac | Active comparator | Drug: Lornoxicam 8 Mg Oral TabletEtodolac, 400 mg tid per a day for four days |
| Lornoxicam | Active comparator | Drug: Lornoxicam 8 Mg Oral TabletLornoxicam, 8 mg twice per day for four days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Bilateral mesioangular impacted lower third molar
- Asymptomatic Third Molar (No history of infection)
- Systemically Healthy Person
- Person Between aged 18-30
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lornoxicam 8 Mg Oral TabletAlso: EtodolacLornoxicam is a oxicam grup non-steroid antiinflamatuar drug | Drug | Etodolac, Lornoxicam |
Primary outcome
Pain after wisdom tooth extraction
Time frame: 2 th hours
Pain after lower third molar removal, Pain was evaluated with VAS(visual anolog scale)
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
Trismus after wisdom tooth extraction
Time frame: 48 th hours,
Trismus lower third molar removal, trismus was evaluated by using caliper
6 secondary outcomes
Pain after wisdom tooth extraction
Time frame: 6 th hours
Pain after wisdom tooth extraction
Time frame: 12 th hours
Pain after wisdom tooth extraction
Time frame: 24 th hours
Pain after wisdom tooth extraction
Time frame: 48 th hours
Edema after wisdom tooth extraction
Time frame: 168 th hours
Trismus after wisdom tooth extraction
Time frame: 168 th hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lornoxicam 8 Mg Oral Tablet in people with Pain, Acute and Edema, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after wisdom tooth extraction (time frame: 2 th hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.