The Effect of Piroxicam Addition During Arthrocentesis on Mouth Opening and Postoperative Pain

NCT06508203 | Completed

• 1 other identifier: 953mscfdasu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

TMDs is an ancient condition discovered thousands of years ago. Historians state that the ancient Egyptians were the first who managed TMDs. They manually treated joint dislocation by away similar to ours nowadays. In the fifth century B.C, Hippocrates described technique for management of mandibular dislocation followed by concerns similar to fixation. At first the surgical management was performed to treat ankylosis and recurrent dislocation. The first surgical repositioning of articular disc done by Annandale in 1887. Lanz, Pringle and Wakeley were the first surgeons who did surgical removal of articular disc in the early 1900s. Their purpose was to manage signs and symptoms of TMDs which is pain, trismus clicking and limitation of movement. In addition, in the late 1800s, dentists' concerns changed toward occlusal adjustment during replacement of natural teeth and prosthetics procedures to avoid TMDs. At the beginning of the 20th century, dentists and otolaryngologists were ascribing head, face, ear, and jaw symptoms to pressure atrophy of the meniscus, glenoid fossa, and cranium as a result of the loss of posterior teeth. However, it was not until 1934 that "TMJ" became universally recognized when Costen, an otolaryngologist, published his discoveries claiming that pain in and around the jaw. Symptoms of Costen syndrome includes impaired hearing, ear pain, tinnitus, dizziness, burning sensation in throat and tongue, headache and trismus. Costen stated that the previous symptoms occur as a result of atrophic or perforated menisci, compression of Eustachian tube, erosion of bone of glenoid fossa and irritation of temporal and corda tympani nerve. On the other hand, in 1926, McCollum founded the Gnathological Society of California. Stallard had already coined the word "gnathology" in 1924. Gnathology is the harmonization of occlusal and inter jaw relationship for optimum dental and TMDs treatment. In addition, Kingsley in 1887 was the first to publish information on intraoral appliances (occlusal splint). Thompson in 1940s considered a leader in mandibular repositioning and rest position intraoral appliances. Shore advanced his concept of auto repositioning the mandible in the 1950s to fully seat the condyle, and Sears reintroduced pivot appliances in the late 1950s to "unload the condyle." Ramjford popularized the use of occlusal splints in the 1960s on the basis of his electromyographic. All the previous work depends on gnathonic concepts. Also, in 1960s Gelb introduced mandibular orthopedic repositioning appliance (MORA) to adjust condyle in its normal position. It has one risk which is irreversible changes in occlusal occurred with full time wear. By the late 1940s Schwartz explained the importance of masticatory musculature and specifically emotional tension as a primary etiologic factor for TMDs. Regional and referred pain of myofascial origin was considered to have a great effect on these conditions. It could be treated by physical medicine. By 1996 the AAOP published new guidelines on orofacial pain classification assessment and management. In addition, Guidelines for TMDs which are:

1. 1.Temporomandibular disorders (TMD) are defined as a collective term consists of a number of clinical problems that include the muscles of mastication, the temporomandibular joint and surrounding structures, or both.
2. 2.Temporomandibular disorders (TMD) are characterized by the following clinical presentation: pain in the muscles of mastication, the preauricular area and/or TMJ that is usually aggravated by manipulation or function; in addition to limited range of motion, abnormal mandibular movement, and locking of the joint. In addition to clicking
3. 3.Common complaints as headache, earache, and orofacial pain, as well as masticatory muscle hypertrophy and abnormal occlusal wearing addition to tinnitus, ear fullness.
4. 4.Cross-sectional epidemiologic studies of a specific nonpatient population show that approximately 75% have at least one sign and approximately 33% have at least one symptom; however, only 5% to 7% are estimated to need treatment. Prevalence data from clinical reports reveal a female to male ratio of 4:1 to 6:1 in persons seeking care, primarily in the second through the fourth decade of life.1 One of the recent treatment modalities of TMJ problems and TMDs is arthrocentesis (joint lavage).

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

• mouth opening

  un assited mouth opening in mm

  six months

Study Arms (2)

study group

EXPERIMENTAL

20 patients will be treated by arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) (study group).

Procedure: arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)

control

ACTIVE COMPARATOR

20 patients will be treated by arthrocentesis with lactate ringer only (control group).

Procedure: arthrocentesis with lactate ringer only

Interventions

arthrocentesis with lactate ringer only PROCEDURE

classical arthrocentesis with lactate ringer only (control group).

control

arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg) PROCEDURE

classical arthrocentesis with lactate ringer followed by injection with piroxicam 2 ml (40mg)

study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age range 18-60 years both gender 2. Patient have gone on noninvasive therapy (occlusal stent) for three months without good prognosis 3. Internal derangement of TMJ (ant. Disc displacement with reduction) 4. Localized TMJ pain

You may not qualify if:

• \. Psychiatric illness 2. Previous TMJ surgery 3. Suffering from joint trauma 4. Cellulitis or severe laceration of pre-auricular skin covering TMJ

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams University

Cairo, 11757, Egypt

Location

Related Publications (1)

• Baruffi S, Saber AY, Martins T, Varacallo MA. Shoulder Arthrocentesis Technique. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519052/

  PMID: 30085594 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis; Piroxicam

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arm randomized clinical trial with study group and positive control

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 18, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-01

Locations

EG (1)