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

Treatment of Temporomandibular Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01958879

Enrollment

Registered

2013-10-09

Start date

2012-09-30

Completion date

2013-11-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrocentesis, Pain, Temporomandibular Joint Dysfunction

Keywords

internal derangement,arthrocentesis,corticosteroid

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.

Interventions

DRUGringer with corticosteroid

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

DRUGringer without corticosteroid

200 mL Ringer solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
pain	6 months	Pain will be assessed preoperatively and again at 1 and 6 months using a visual analogue scale

Secondary

Measure	Time frame	Description
function	6 months	Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026