NCT06766851

Brief Summary

The study focused on arthrocentesis performed using a catheter, aiming to assess its effects on pain perception and mouth opening in patients with TMJ disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

January 4, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Branul

Outcome Measures

Primary Outcomes (2)

  • The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.

    Preopretive, Postoperative 1st day, 1st week and 1st month

  • Change in post-operative pain assessed

    A visual analog scale (VAS) was used, grading from 1 to 10 (1: no pain, 10: unbearable pain)

    Preoperative, Postoperative 1st day, 1st week and 1st month

Study Arms (2)

Catheter group

EXPERIMENTAL

Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with catheter arthrocentesis. The upper joint space was entered with a 16 gauge 45 mm long branul. The 16 gauge metal cannula was removed and the plastic sheath was left in the upper joint space. The 18 gauge metal cannula, which was 1 size smaller, was placed inside the sheath. The irrigation solution was administered through the 18 gauge metal cannula and the irrigation solution flowed out of the space between the cannula and the sheath + I-PRF

Other: Procedure: TMJ Arthrocentesis

conventional single needle group

ACTIVE COMPARATOR

Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis + I-PRF

Other: Procedure: TMJ Arthrocentesis

Interventions

Temporomandibular joint arthrocentesis

Catheter groupconventional single needle group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

Location

Related Publications (2)

  • Hasanoglu Erbasar GN, Senturk MF, Sancak K. The Short-Term Results of the Modified Concentric-Needle Technique for Single-Puncture Arthrocentesis: A Preliminary Study. J Coll Physicians Surg Pak. 2024 Jun;34(6):717-722. doi: 10.29271/jcpsp.2024.06.717.

    PMID: 38840358BACKGROUND
  • Senturk MF, Yazici T, Gulsen U. Techniques and modifications for TMJ arthrocentesis: A literature review. Cranio. 2018 Sep;36(5):332-340. doi: 10.1080/08869634.2017.1340226. Epub 2017 Jun 15.

    PMID: 28618972BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 9, 2025

Study Start

December 13, 2024

Primary Completion

August 15, 2025

Study Completion

September 15, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations