NCT06055855

Brief Summary

The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are: Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort? Participants will: Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis. Be monitored for operation time, postoperative pain, and overall patient comfort. Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

September 20, 2023

Last Update Submit

July 11, 2024

Conditions

Temporomandibular Joint Disorders

Keywords

Arthrocentesis,Temporomandibular JointGuided surgery

Outcome Measures

Primary Outcomes (1)

  • Total Duration of Arthrocentesis Procedure

    he primary outcome measure of the study is the total time duration required to complete the arthrocentesis procedure. This duration will be measured from the time local anesthesia is administered to the time when the arthrocentesis is completed. In addition, the number of intraoperative repositions of the needles will also be recorded.

    Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.

Secondary Outcomes (4)

  • Volume of Ringer's Solution Used for Joint Irrigation

    Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.

  • Change in Postoperative Pain

    7 days

  • Change in Mouth Opening

    7 days

  • Change in Facial Swelling

    7 days

Study Arms (2)

Traditional Arthrocentesis Group

ACTIVE COMPARATOR
Procedure: Traditional Two-Needle Arthrocentesis

Surgery-Guided Arthrocentesis Group

EXPERIMENTAL
Procedure: Surgery-Guided Arthrocentesis

Interventions

Traditional Two-Needle ArthrocentesisPROCEDURE

Participants in this group will undergo arthrocentesis using the traditional two-needle technique. The procedure involves the placement of one or two needles into the temporomandibular joint (TMJ) to irrigate the joint space. Needle placement is guided by anatomical landmarks.

Traditional Arthrocentesis Group
Surgery-Guided ArthrocentesisPROCEDURE

Participants in this group will receive arthrocentesis facilitated by a surgical guide. The guide is generated through pre-operative planning and is designed to aid in the accurate placement of the needle into the TMJ.

Surgery-Guided Arthrocentesis Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
  • Presence of pain, sound, or both in the TMJ.
  • Limitation or locking in mouth opening, or both.
  • Patients who have not responded to symptoms after a minimum of three months of splint therapy.

You may not qualify if:

  • Presence of infection in the puncture area.
  • Presence of osteomyelitis in the neighboring region.
  • Patients with uncontrolled coagulopathies.
  • Patients experiencing limitation in maximum mouth opening without disk disorder.
  • Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
  • History of TMJ surgery.
  • History of muscle-originated mandibular hypomobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

September 10, 2023

Primary Completion

February 10, 2024

Study Completion

February 10, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

TU(1)