Dental PainPhase 4NCT06704113
Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients
A Phase 4 study testing meloxicam 7,5mg in people with Dental Pain and Sensation Disorders, run by Universidad Austral de Chile.
Trial summary
Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain, Sensation Disorders
- What is being tested?
- meloxicam 7,5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 20 Jan 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maxillary or mandibular third molar with semi or fully erupted crown.
Who cannot join
- Patients with Systemic pathologies. Presence of third molar localized infection. Completely included third molar crown. Periodontal compromise. Pregnant or breastfeeding women. Patients with hypersensitivity to NSAIDs. Patients with a history of drug abuse. Patients who had taken any drug in the previous 24 hours. Intervention (exodontia) time longer than 45 minutes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Efficacy of Meloxicam Versus Ibuprofen for Pain Control After Third Molar Extraction in Adult Patients: Randomized Clinical Trial
Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure.
Read the detailed description
Summary: Third molar extractions are one of the most common procedures in dental practice. However, pain and swelling as postoperative sequelae are inevitable. Depending on the level of pain, which can range from moderate to severe, this symptomatology can be accompanied with pharmacological treatment, thus generating a less traumatic recovery for the patient. It is currently known that non-steroidal anti-inflammatory drugs (NSAIDs) have proven to be effective for the treatment of mild and moderate postoperative pain. Due to the wide variety of NSAIDs, it is important to know how to choose the most effective option when indicating one therapeutic option over another.
Objective: To evaluate the postoperative analgesic effectiveness of meloxicam (7.5 mg) compared to ibuprofen (400 mg) in patients undergoing third molar(s) extraction.
Design: Randomized controlled clinical trial, double-masked, designed according to CONSORT guideline requirements.
- Conditions
- Dental Pain, Sensation Disorders
- Being tested
- meloxicam 7,5mg
- Keywords
- Tooth Extraction, Molar, Third, Meloxicam, Ibuprofen
- Medical subject headings
- Toothache, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meloxicam 7,5mgDrug
Also called ibuprofen 400mg
Comparison of analgesic efficacy of Meloxicam Vs Ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| Group A control. Ibuprofen | Active comparator | Ibuprofen 400mg tablets, 1 every 8 hours for 3 days will be administered for post-surgical pain. Receives: Drug: meloxicam 7,5mg |
| Group B experimental. Meloxicam | Active comparator | Meloxicam 7.5mg tablets, 1 every 12 hours for 3 days will be administered for post-surgical pain. Receives: Drug: meloxicam 7,5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meloxicam effectiveness for post-surgical pain control.
A visual analogue scale ranging from 0 points (no pain) to 10 points (intolerable pain) will be used to measure post-exodontic pain, and values will be recorded on a questionnaire.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Austral de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704113
- Sponsor's protocol ID
- MelvsIbu
- Status last verified
- Nov 2024
- First submitted
- 5 Jul 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haffar A, Fillingham YA, Breckenridge L, Gursay D, Lonner JH. Meloxicam versus Celecoxib for Postoperative Analgesia after Total Knee Arthroplasty: Safety, Efficacy and Cost. J Am Acad Orthop Surg Glob Res Rev. 2022 Apr 5;6(4):e22.00032. doi: 10.5435/JAAOSGlobal-D-22-00032.
PubMed 35389917Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.
PubMed 31026419Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD008659. doi: 10.1002/14651858.CD008659.pub3.
PubMed 26414123Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
PubMed 21350618Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.
PubMed 34922724
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Meloxicam Versus Ibuprofen for Pain Control After Third Molar Extraction in Adult Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06704113
- Acronym / sponsor ID
- MelvsIbu
- Conditions
- Dental Pain, Sensation Disorders
- Keywords
- Tooth Extraction, Molar, Third, Meloxicam, Ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidad Austral de ChileUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 25 Nov 2024 (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.
Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure.
Detailed description
Summary: Third molar extractions are one of the most common procedures in dental practice. However, pain and swelling as postoperative sequelae are inevitable. Depending on the level of pain, which can range from moderate to severe, this symptomatology can be accompanied with pharmacological treatment, thus generating a less traumatic recovery for the patient. It is currently known that non-steroidal anti-inflammatory drugs (NSAIDs) have proven to be effective for the treatment of mild and moderate postoperative pain. Due to the wide variety of NSAIDs, it is important to know how to choose the most effective option when indicating one therapeutic option over another.
Objective: To evaluate the postoperative analgesic effectiveness of meloxicam (7.5 mg) compared to ibuprofen (400 mg) in patients undergoing third molar(s) extraction.
Design: Randomized controlled clinical trial, double-masked, designed according to CONSORT guideline requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A control. Ibuprofen | Active comparator | Drug: meloxicam 7,5mgIbuprofen 400mg tablets, 1 every 8 hours for 3 days will be administered for post-surgical pain. |
| Group B experimental. Meloxicam | Active comparator | Drug: meloxicam 7,5mgMeloxicam 7.5mg tablets, 1 every 12 hours for 3 days will be administered for post-surgical pain. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Maxillary or mandibular third molar with semi or fully erupted crown.
Key exclusion criteria (1 listed)
- Patients with Systemic pathologies. Presence of third molar localized infection. Completely included third molar crown. Periodontal compromise. Pregnant or breastfeeding women. Patients with hypersensitivity to NSAIDs. Patients with a history of drug abuse. Patients who had taken any drug in the previous 24 hours. Intervention (exodontia) time longer than 45 minutes.
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 |
|---|---|---|
| meloxicam 7,5mgAlso: ibuprofen 400mgComparison of analgesic efficacy of Meloxicam Vs Ibuprofen | Drug | Group A control. Ibuprofen, Group B experimental. Meloxicam |
Primary outcome
Meloxicam effectiveness for post-surgical pain control.
Time frame: 3 days
A visual analogue scale ranging from 0 points (no pain) to 10 points (intolerable pain) will be used to measure post-exodontic pain, and values will be recorded on a questionnaire.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 35389917Haffar A, Fillingham YA, Breckenridge L, Gursay D, Lonner JH. Meloxicam versus Celecoxib for Postoperative Analgesia after Total Knee Arthroplasty: Safety, Efficacy and Cost. J Am Acad Orthop Surg Glob Res Rev. 2022 Apr 5;6(4):e22.00032. doi: 10.5435/JAAOSGlobal-D-22-00032.
- Background: PubMed 31026419Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.
- Background: PubMed 26414123Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD008659. doi: 10.1002/14651858.CD008659.pub3.
- Background: PubMed 21350618Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
- Background: PubMed 34922724Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing meloxicam 7,5mg in people with Dental Pain and Sensation Disorders, run by Universidad Austral de Chile.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla C Bertran, DDS (56632228028, carlabertran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meloxicam effectiveness for post-surgical pain control. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704113, which also lists 5 linked publications.
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 25 Nov 2024.