Clinical trial NCT01958879: Efficacy of Arthrocentesis by Injection of Ringer With or Without Corticosteroid in Treatment of Internal Derangement
Official title: Treatment of Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Dysfunction
Pain
Arthrocentesis
Keywords: internal derangement,arthrocentesis,corticosteroid
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This prospective clinical study was approved by Local ethical committee and written informed consent will be obtained before the trial starts. Criteria for selection of the patients was based on history and clinical findings characteristic of internal derangement. All these patients were initially treated with NSAIDS for 1 week and occlusal splints for 1 month had failed to respond to these conservative treatments. The patients with systemic problems which affect bone and joints,psychological problems ,history of maxillofacial fractures and orthognathic surgery were excluded from the study. A total of 60 patients with TMJ internal derangement with failed conservative management, were subjected to TMJ arthrocentesis. All arthrocentesis were performed by the same maxillofacial surgeon. Subjects were randomly allocated into two groups (30 cases in each group). Subjects in the group 1 received irrigation with Ringer solution and in the group 2 ,subjects underwent irrigation with Ringer solution with corticosteroid (Dexamethasone ) .Two examiners evaluated Temporomandibular disorder's signs ( mouth opening,click , crepitus and pain) before, one month and 6 months after arthrocentesis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: pain
timeFrame: 6 months
Secondary outcomes:
measure: function
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz university of medical sciences
Study officials:
affiliation: SUMS
name: Reza Tabrizi, DMD
role: STUDY_CHAIR
affiliation: SUMS
name: Reza Tabrizi, DMD
role: STUDY_DIRECTOR
affiliation: SUMS
name: Touba Karagah, DMD
role: PRINCIPAL_INVESTIGATOR
References: