Comparison of Different Drugs on Pain and Trismus in Patients With Temporomandibular Disorder

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ClinicalTrials.gov Identifier: NCT04066426

Recruitment Status : Completed

First Posted : August 26, 2019

Last Update Posted : August 26, 2019

Sponsor:

Information provided by (Responsible Party):

levent Cigerim, Yuzuncu Yıl University

Study Description

Brief Summary:

Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics.1 Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs maybe 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 and trismus in patients complaining from temporomandibular pain.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Disorder	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	169 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Comparison of Effects of Naproxen Sodium-codeine Phosphate in Combination, Naproxen Sodium + Single Dose Dexamethasone and Naproxen Sodium Alone on Pain and Trismus in Patients With Temporomandibular Disorder
Actual Study Start Date :	March 1, 2018
Actual Primary Completion Date :	April 1, 2019
Actual Study Completion Date :	July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Temporomandibular Joint Dysfunction

Drug Information available for: Dexamethasone Codeine Dexamethasone sodium phosphate Phosphate ion Naproxen Naproxen sodium Codeine phosphate Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: naproxen sodium+codeine phosphate 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.	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders. Other Name: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Experimental: naproxen sodium+dexamethasone 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.	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders. Other Name: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Experimental: naproxen sodium 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.	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders. Other Name: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Active Comparator: paracetamol 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.	Drug: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders. Other Name: Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol

Outcome Measures

Primary Outcome Measures :

Pain evaluation [ Time Frame: Evaluations were carried out pre-treatment (baseline) and at the first week, second week and first month during treatment. ]
Evaluation of changes in Visual Analog Scale (VAS) measurements by groups

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066426

Locations

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

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

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Study Chair:	Volkan KAPLAN, PhD	Faculty of dentistry

More Information

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Responsible Party:	levent Cigerim, Head of Oral and Maxillofacial Surgery Department, Yuzuncu Yıl University
ClinicalTrials.gov Identifier:	NCT04066426 History of Changes
Other Study ID Numbers:	16.02.2018/12
First Posted:	August 26, 2019 Key Record Dates
Last Update Posted:	August 26, 2019
Last Verified:	August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by levent Cigerim, Yuzuncu Yıl University:


naproxen sodium codeine phosphate dexamethasone	pain trismus temporomandibular joint

Additional relevant MeSH terms:

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Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Trismus Disease Pathologic Processes Craniomandibular Disorders Mandibular Diseases Jaw Diseases Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Spasm Neuromuscular Manifestations	Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Dexamethasone Dexamethasone acetate Naproxen Codeine BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents

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