Arthrocentesis Versus Operative Arthroscopy Treatment of TMJ Internal Derangement (TMJ)

NCT04308460 | Completed

• 1 other identifier: arthrocenetesis vs arthroscopy
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

Introduction: Temporomandibular disorders (TMDs) are relatively common conditions and internal derangement is the most common among them. Different methods have been suggested for treatment , beginning with conservative approaches ending with surgery. Nowadays, arthroscopy and arthrocentesis have eliminated the use of many of the more complex surgical procedures. Despite such advancements, there is lack of prospective, randomized, clinical studies to support the use of either both. In doing the necessary studies, and comparing the results, it will be important to develop standardized patient selection criteria and treatment options to be used by all investigators. Objectives: To compare between arthrocentesis and operative arthroscopy in the management of patients with internal derangement of temporomandibular joint stage II and III Wilkes. Materials and Methods: a prospective study was done on 40 patients with temporomandibular joint internal derangement and were divided into 2 groups, 20 patients were treated with arthrocentesis and 20 patients were treated with operative arthroscopy.

Conditions

Temporomandibular Joint Disc Displacement; Temporomandibular Joint Disorders

Keywords

TMJ, TMJ arthroscopy, arthroscopy, arthrocentesis

Outcome Measures

Primary Outcomes (1)

• mouth opening

  mouth opening was measured using the maximum interincisal opening in millimeter

  6 months

Secondary Outcomes (3)

• post operative pain score

  6 months

• protrusive movement

  6 months

• lateral excursion movement

  6 months

Study Arms (2)

arthrocentesis group

ACTIVE COMPARATOR

the group of internal derangement patients which was treated with arthrocentesis procedure

Procedure: arthrocentesis

operative arthroscopy group

ACTIVE COMPARATOR

the group of internal derangement patients which was treated with operative arthroscopy procedure

Procedure: operative arthroscopy

Interventions

arthrocentesis PROCEDURE

lavage of the temporomandibular joint was done

arthrocentesis group

operative arthroscopy PROCEDURE

operative intervention inside the temporomandibular joint was done using arthroscope

operative arthroscopy group

Eligibility Criteria

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

You may qualify if:

• The patients with TMJ internal derangement will be divided into 5 stages according to Wilkes Classification. Only patients with stages II and III will be included in this study.

You may not qualify if:

• Medically unfit patients.
• Stages I, IV \& V Wilkes (Stage I patients will get benefit from conservative treatment and stage IV and V represent an advanced stages).
• Patients with TMDs secondary to malocclusion.
• Psychological instability.
• Patients operated before for other TMJ problems.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (2)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

University Hospital of Badajoz

Badajoz, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mohamed H Warda, PhD

  Alexandria University

  STUDY DIRECTOR

• Mohamed M Fata, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Ahmed M Medra, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Florencio G Monje, PhD

  University Hospital of badajoz, Sapin

  PRINCIPAL INVESTIGATOR

• Aly M Atteya, MS

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 16, 2020
• Study Start: January 10, 2017
• Primary Completion: June 10, 2019
• Study Completion: December 16, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: the sharing access can be through PubMed when the study is published or through direct contact through this email: aly\ atteya@hotmail.com

Locations

EG (1); ES (1)