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

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01958879

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Dysfunction Pain Arthrocentesis	Drug: ringer with corticosteroid Drug: ringer without corticosteroid	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Treatment of Temporomandibular Disorder

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ringer with corticosteroid 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 200 mL Ringer solution+1mg dexamethasone after finishing the irrigation
Placebo Comparator: Ringer with out corticosteroid 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 200 mL Ringer solution

Arm

Intervention/Treatment

Experimental: ringer with corticosteroid

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

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

Placebo Comparator: Ringer with out corticosteroid

Drug: ringer without corticosteroid

200 mL Ringer solution

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

function [6 months]
Mouth opening was measured as the maximum interincisal distance in millimeters using a scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiraz university of medical sciences	Shiraz		Iran, Islamic Republic of

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

Study Chair: Reza Tabrizi, DMD, SUMS
Study Director: Reza Tabrizi, DMD, SUMS
Principal Investigator: Touba Karagah, DMD, SUMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reza Tabrizi, OMFS, Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01958879

Other Study ID Numbers:

12345

First Posted:

Oct 9, 2013

Last Update Posted:

Oct 7, 2014

Last Verified:

Oct 1, 2013

Keywords provided by Reza Tabrizi, OMFS, Shiraz University of Medical Sciences

internal derangement,arthrocentesis,corticosteroid

Additional relevant MeSH terms:

Joint Diseases

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Oct 7, 2014