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OpenTrials
Completed

NCT Number: NCT01958879

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ringer with corticosteroid

Drug

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

ringer without corticosteroid

Drug

200 mL Ringer solution

Primary outcomes

  1. pain

    Time frame: 6 months

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

Secondary outcomes

  1. function

    Time frame: 6 months

    Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Treatment of Temporomandibular Disorder

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 9, 2013
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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