Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement

NCT01958879 | Completed Phase 2 DMC

• 1 other identifier: 12345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate effectiveness of ringer injection with or without corticosteroid during arthrocentesis of the temporomandibular joint in the treatment of internal derangement of the temporomandibular joint (TMJ).

Conditions

Temporomandibular Joint Dysfunction; Pain; Arthrocentesis

Keywords

internal derangement,arthrocentesis,corticosteroid

Outcome Measures

Primary Outcomes (1)

• pain

  Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale

  6 months

Secondary Outcomes (1)

• function

  6 months

Study Arms (2)

ringer with corticosteroid

EXPERIMENTAL

Intra-articular irrigation was performed under local anesthesia with subcutaneous injection of 1%lidocaine solution (0.6 to 0.9 mL anaesthetic solution )was injected to block the auriculotemporal nerve. Then the skin on the TMJ was penetrated with a 21-gauge needle at the articular fossa followed by the injection of 3 mL Ringer solution to distend the joint space, pumping it in and out repeatedly. Another 21-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL Ringer solution, allowing a free flow through the first needle in the both groups .In this group patients received 1mg dexamethasone after finishing the irrigation .

Drug: ringer with corticosteroid

Ringer with out corticosteroid

PLACEBO COMPARATOR

Intra-articular irrigation was performed under local anesthesia with subcutaneous injection of 1%lidocaine solution (0.6 to 0.9 mL anaesthetic solution )was injected to block the auriculotemporal nerve. Then the skin on the TMJ was penetrated with a 21-gauge needle at the articular fossa followed by the injection of 3 mL Ringer solution to distend the joint space, pumping it in and out repeatedly. Another 21-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL Ringer solution, allowing a free flow through the first needle in the both groups

Drug: ringer without corticosteroid

Interventions

ringer with corticosteroid DRUG

200 mL Ringer solution+1mg dexamethasone after finishing the irrigation

ringer with corticosteroid

ringer without corticosteroid DRUG

200 mL Ringer solution

Ringer with out corticosteroid

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical findings characteristic of internal derangement(clicking and joint pain lasting for more than 6 months) unilaterally or bilaterally and history of previous conservative drug therapy (NSAIDs and Muscle relaxant ),splint therapy and physiotherapy without improvement.
• Patients of both sexes between 15 to 80 year's old
• Patients who are willing for evaluation in 1 and 6 months after arthrocentesis
• Patients who are provided written consent form

You may not qualify if:

• Patient had systemic problems which affect bone and joints disease
• Patient with psychological problems
• Patient with history of maxillofacial fractures and orthognathic
• Patients who can not continue the study for private or social reasons

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shiraz university of medical sciences

Shiraz, Iran

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Reza Tabrizi, DMD

  SUMS

  STUDY CHAIR

• Reza Tabrizi, DMD

  SUMS

  STUDY DIRECTOR

• Touba Karagah, DMD

  SUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OMFS

Study Record Dates

• First Submitted: October 5, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 7, 2014

Record last verified: 2013-10

Locations

IR (1)