Temporomandibular Joint DisordersPhase 2NCT04609748
Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.
A Phase 2 study testing Cannabidiol Oil and Nimesulide in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared. Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain
- What is being tested?
- Cannabidiol Oil and Nimesulide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 27 Jan 2021to 31 Dec 2021
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (female and male) aged 18-65 years, able to swallow tablets
- Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
- Patients with clinical diagnosis of Temporomandibular Joint Dysfunction
Who cannot join
- patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
- patients allergic to nimesulide or cannabidiol oil
- patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:
- gastric or duodenal ulcer disease,
- severe blood clotting disorders,
- severe liver dysfunction,
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- severe renal impairment,
- severe heart failure, pregnancy,
- breastfeeding,
- concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)
Trial locations and contacts
1 site in 1 country.
Kamila Szczuchniak, DMD contact
Poland1 site, 1 recruiting
- Recruiting
Chair and Depratment of Dental Prosthetics
Szczecin
Bartosz Dalewski, DMD, PhD, bartosz.dalewski@pum.edu.pl
Kamila Szczuchniak, DMD
About this study
During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain
- Being tested
- Cannabidiol Oil, Nimesulide
- Keywords
- temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol OilDrug
Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.
NimesulideDrug
Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.
| Study group | Role | What they receive |
|---|---|---|
| The group that received nimesulide | Active comparator | Not described Receives: Drug: Nimesulide |
| The group that received CBD Oil | Experimental | Not described Receives: Drug: Cannabidiol Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured on Visual Analogue Scale (VAS) scale. It consists of a line, approximately 100mm in length, at the left end of the scale "Score 0" which means "no pain", at the right end of the scale "Score 100mm" which means "worst imaginable pain"
Measured: 15 days
Psychological conditions
Measured on The General Health Questionnaire-28 (GHQ-28)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start27 Jan 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalewski Bartosz, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609748
- Sponsor's protocol ID
- KB-0012/149/2020
- Status last verified
- Jan 2021
- First submitted
- 26 Oct 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.
- ClinicalTrials.gov ID
- NCT04609748
- Acronym / sponsor ID
- KB-0012/149/2020
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain
- Keywords
- temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Oct 2020 (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.
During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group that received nimesulide | Active comparator | Drug: Nimesulide |
| The group that received CBD Oil | Experimental | Drug: Cannabidiol Oil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (female and male) aged 18-65 years, able to swallow tablets
- Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
- Patients with clinical diagnosis of Temporomandibular Joint Dysfunction
Key exclusion criteria (10 listed)
- patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
- patients allergic to nimesulide or cannabidiol oil
- patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:
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 |
|---|---|---|
| Cannabidiol OilCannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days. | Drug | The group that received CBD Oil |
| NimesulideNimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days. | Drug | The group that received nimesulide |
Primary outcome
Pain relief
Time frame: 15 days
Measured on Visual Analogue Scale (VAS) scale. It consists of a line, approximately 100mm in length, at the left end of the scale "Score 0" which means "no pain", at the right end of the scale "Score 100mm" which means "worst imaginable pain"
Psychological conditions
Time frame: 15 days
Measured on The General Health Questionnaire-28 (GHQ-28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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.
Kamila Szczuchniak, DMD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol Oil and Nimesulide in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Dalewski, DMD, PhD (914661717, bartosz.dalewski@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 15 days). The study lists 2 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 29 Jan 2021.