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

NCT06667791 | Completed

• 1 other identifier: 0870-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  Baseline,1 months, and 3 months

Secondary Outcomes (2)

• Duration of operation

  Baseline

• Number of Needle Relocation

  Baseline

Study Arms (2)

Study Group

EXPERIMENTAL

Other: Computer guided sodium hyaluronate injections

Control

ACTIVE COMPARATOR

Other: conventional sodiumhyaluronate injections

Interventions

Computer guided sodium hyaluronate injections OTHER

Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space

Study Group

conventional sodiumhyaluronate injections OTHER

Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space

Control

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient clinic of Oral and Maxillofacial Surgery

Alexandria, 00302, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

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

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 of Dental Public Health and biostatistical consultant

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: May 3, 2024
• Primary Completion: August 21, 2024
• Study Completion: October 24, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

EG (1)