Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

Hams Hamed Abdelrahman20 enrolled

Overview

Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point. Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Temporomandibular Disorder

Interventions

Computer guided sodium hyaluronate injections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Patients diagnosed with internal derangement according to Wilkins stage I and II. * Patients who would not respond to conservative treatment as a first line of treatment. Exclusion Criteria: * Patients with Wilkins stage III, IV, V. * History of mandibular fracture. * Lactating, pregnant or planning pregnancy women. * Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Outcomes

Primary Outcomes

Change in TMJ dysfunction

A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows: * Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors. * Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if \<2 mm, score 1 - if 2-5 mm, and score 5 - if \>5 mm

Time frame: Baseline, 1 month, and 3 months

change in pain score

Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).

Time frame: Baseline,1 months, and 3 months

Secondary Outcomes

Duration of operation

Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure.

Time frame: Baseline

Number of Needle Relocation

The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis.