Temporomandibular DisorderPhase 4NCT04066426

Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain

A Phase 4 study testing naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol in people with Temporomandibular Disorder, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Temporomandibular Disorder
What is being tested?: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Mar 2018to 15 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Without a systemic disease,
Not used any medication in the last week
Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

Who cannot join

Individuals who smoke
Have a parafunctional habits (except for squeezing and grinding teeth)
Pregnant and breastfeeding individuals
Allergies to study medicines
Do not use their medications / use different drugs and non-follow-up

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Van Yuzuncu Yil University, Faculty of Dentistry
Van, Tuşba, 65080

Other trials in Turkey (Türkiye)

About this study

Official title: Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial

Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain.

Conditions: Temporomandibular Disorder
Being tested: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
Keywords: naproxen sodium, codeine phosphate, dexamethasone, pain, temporomandibular joint
Medical subject headings: Temporomandibular Joint Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolDrug
Also called Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.

Study groups in NCT04066426
Study group	Role	What they receive
naproxen sodium+codeine phosphate	Experimental	Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study. Receives: Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
naproxen sodium+dexamethasone	Experimental	Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study. Receives: Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
naproxen sodium	Experimental	Naproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study. Receives: Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
paracetamol	Active comparator	Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea. Receives: Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
Measured: Pre-treatment (baseline)
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Measured: At the first week
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Measured: At the second week
Pain Evaluation
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Measured: At the first month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201815 Jul 2019

First posted26 Aug 2019
Study start1 Mar 2018
Primary completion1 Apr 2019
Study completion15 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Temporomandibular DisorderStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066426
Sponsor's protocol ID: 16.02.2018/12
Status last verified: Jan 2021
First submitted: 17 Aug 2019
Last updated: 15 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial
ClinicalTrials.gov ID: NCT04066426
Acronym / sponsor ID: 16.02.2018/12
Conditions: Temporomandibular Disorder
Keywords: naproxen sodium, codeine phosphate, dexamethasone, pain, temporomandibular joint
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Yuzuncu Yil UniversityUniversity, hospital or other
Study start: 1 Mar 2018 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 26 Aug 2019 (actual)
Results: Posted 15 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
naproxen sodium+codeine phosphate	Experimental	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolNaproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Codeine phosphate is an opioid analgesic which has similar applications to those of morphine. However, it is significantly less potent as an analgesic and has only mild sedative effects. The drug's principal site of action is at the µ-opioid receptors (MOR) which are distributed in the central nervous system. Peak effect is reached within 2 hours and analgesic action continues for approximately 4 hours. Naproxen sodium (550 mg)+codeine phosphate (30 mg) was used twice daily in this study.
naproxen sodium+dexamethasone	Experimental	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolNaproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily + dexamethasone (8 mg) was used once daily in this study.
naproxen sodium	Experimental	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolNaproxen sodium is a propionic acid derivative with analgesic, antipyretic, and antiinflammatory properties. Its mechanism of action relies on the inhibition of prostaglandin synthesis, and significant pain relief and plasma levels can be obtained within 20 minutes following intake. The elimination half-life of naproxen sodium is reportedly around 14 hours, and naproxen sodium is used in doses ranging from 275 to 550 mg in surgical procedures. Naproxen sodium (550 mg) was used twice daily in this study.
paracetamol	Active comparator	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolParacetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Without a systemic disease,
Not used any medication in the last week
Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region

Key exclusion criteria (5 listed)

Individuals who smoke
Have a parafunctional habits (except for squeezing and grinding teeth)
Pregnant and breastfeeding individuals
Allergies to study medicines
Do not use their medications / use different drugs and non-follow-up

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
naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamolAlso: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, ParmolNSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.	Drug	naproxen sodium, naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, paracetamol

Primary outcome

Pain Evaluation
Time frame: Pre-treatment (baseline)
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain)
Pain Evaluation
Time frame: At the first week
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Pain Evaluation
Time frame: At the second week
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).
Pain Evaluation
Time frame: At the first month
Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain).

Results and safety

Results posted to the registry on 15 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naproxen Sodium+Codeine Phosphate	50	40
Naproxen Sodium+Dexamethasone	50	40
Naproxen Sodium	50	42
Paracetamol	50	47

Primary outcome: Pain Evaluation

Time frame: Pre-treatment (baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	Naproxen Sodium+Codeine Phosphate n = 40	Naproxen Sodium+Dexamethasone n = 40	Naproxen Sodium n = 42	Paracetamol n = 47
Value	6.38 (1.86)	6.93 (1.76)	5.76 (2.74)	5.49 (2.73)

Primary outcome: Pain Evaluation

Time frame: At the first week. Mean (Standard Deviation). Unit: score on a scale

Measure	Naproxen Sodium+Codeine Phosphate n = 40	Naproxen Sodium+Dexamethasone n = 40	Naproxen Sodium n = 42	Paracetamol n = 47
Value	4.68 (1.82)	5.93 (2.22)	4.95 (2.85)	4.60 (2.89)

Primary outcome: Pain Evaluation

Time frame: At the second week. Mean (Standard Deviation). Unit: score on a scale

Measure	Naproxen Sodium+Codeine Phosphate n = 40	Naproxen Sodium+Dexamethasone n = 40	Naproxen Sodium n = 42	Paracetamol n = 47
Value	3.58 (1.69)	5.28 (2.36)	4.33 (2.78)	4.34 (3.03)

Primary outcome: Pain Evaluation

Time frame: At the first month. Mean (Standard Deviation). Unit: score on a scale

Measure	Naproxen Sodium+Codeine Phosphate n = 40	Naproxen Sodium+Dexamethasone n = 40	Naproxen Sodium n = 42	Paracetamol n = 47
Value	2.93 (1.65)	5.28 (2.50)	3.69 (2.71)	4.38 (2.96)

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naproxen Sodium+Codeine Phosphate	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Naproxen Sodium+Dexamethasone	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Naproxen Sodium	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Paracetamol	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Limitations and caveats (from the sponsor): The diversity of the individuals in the groups was the limitation of this study. Different individual characteristics may change the efficacy of drugs in groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Temporomandibular Disorder

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
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Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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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.

Volkan KAPLAN, PhD study chair

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 15 Feb 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 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?

Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Evaluation (time frame: Pre-treatment (baseline)). The study lists 4 primary outcomes in all. 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 NCT04066426.

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 15 Feb 2021.