Unilateral TMJ Discectomy Without Interposal Material in Patients With Disc Perforation or Fragmentation

NCT04857294 | Completed

• 1 other identifier: TMJDISCECT
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for painful TMJ. Previous studies have demonstrated predictable results of discectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement. However, those studies had most of the times varied inclusion criteria. A 4-year prospective study was designed including patients treated with unilateral TMJ discectomy without interposal material as the first surgical procedure for two specific intra-articular diagnosis: disc perforation and disc fragmentation.

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular; TMJ Discectomy; TMJ Meniscectomy; TMJ Surgery

Outcome Measures

Primary Outcomes (2)

• Pain (Visual Analogue Scale (0,10)

  VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

  Pre-surgery

• Pain (Visual Analogue Scale (0,10)

  VAS, 0-10, with 0 being no pain and 10 having maximum unbearable pain

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Maximum mouth opening (MMO, mm)

  Pre-surgery

• Maximum mouth opening (MMO, mm)

  Through study completion, an average of 2 years

• Muscle tenderness (0-3 scale)

  Pre-surgery

• Muscle tenderness (0-3 scale)

  Through study completion, an average of 2 years

Study Arms (1)

Discectomy

EXPERIMENTAL

Unilateral Discectomy

Procedure: TMJ unilateral discectomy

Interventions

TMJ unilateral discectomy PROCEDURE

All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.

Discectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old;
• Unilateral TMJ pain \>7 (0-10 VAS) and/or MMO \< 30mm;
• MRI presenting unilateral disc perforation or disc fragmentation
• Clinical and imaging examination with criteria for unilateral TMJ discectomy

You may not qualify if:

• Previous TMJ surgical intervention;
• Concomitant contralateral surgery;
• Age \< 18 years old

Sponsors & Collaborators

• Instituto Portugues da Face: lead

Study Sites (1)

Instituto Português da Face

Lisbon, 1050-227, Portugal

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 Officials

• David Ângelo, MD, PhD

  Instituto Português da Face

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Study

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 23, 2021
• Study Start: July 9, 2015
• Primary Completion: December 11, 2020
• Study Completion: January 31, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)