NCT04367259

Brief Summary

The aim of the present study was to compare the treatment efficacy of single puncture arthrocentesis (SPA) and double puncture arthrocentesis (DPA) techniques in Temporomandibular joint (TMJ) disc displacement without reduction (DDwoR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration 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

January 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

April 3, 2020

Last Update Submit

April 27, 2020

Conditions

Arthrocentesis

Keywords

Temporomandibular Joint

Outcome Measures

Primary Outcomes (10)

  • The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    baseline (t0)

  • The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    At 1st week (t1)

  • The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    at 1st month (t2)

  • The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    at 3rd month (t3)

  • The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    at 6th month (t4)

  • 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.

    baseline (t0)

  • 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.

    at 1st week (t1)

  • 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.

    at 1st month (t2)

  • 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.

    at 3rd month (t3)

  • 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.

    at 6th month (t4)

Secondary Outcomes (31)

  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    At Baseline (t0)

  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    at 1st week (t1)

  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    at 1st month (t2)

  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    at 3rd month (t3)

  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    at 6th month (t4)

  • +26 more secondary outcomes

Study Arms (2)

Single puncture arthrocentesis (SPA) group

ACTIVE COMPARATOR

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

Procedure: TMJ Arthrocentesis

Double puncture arthrocentesis (DPA) group

ACTIVE COMPARATOR

Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis

Procedure: TMJ Arthrocentesis

Interventions

TMJ ArthrocentesisPROCEDURE

Temporomandibular joint arthrocentesis

Double puncture arthrocentesis (DPA) groupSingle puncture arthrocentesis (SPA) group

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
  • Restricted mouth opening

You may not qualify if:

  • History of systemic disease effecting TMJ.
  • History of previous TMJ surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Erzincan, Turkey (Türkiye)

Location

Related Publications (2)

  • Bayramoglu Z, Tozoglu S. Comparison of single- and double-puncture arthrocentesis for the treatment of temporomandibular joint disorders: A six-month, prospective study. Cranio. 2021 Mar;39(2):151-156. doi: 10.1080/08869634.2019.1603796. Epub 2019 Apr 25.

    PMID: 31021311RESULT

  • Senturk MF, Yazici T, Findik Y, Baykul T. Intraoperative comparison of single- and double-puncture techniques in temporomandibular joint arthrocentesis. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1060-1064. doi: 10.1016/j.ijom.2018.03.029. Epub 2018 May 1.

    PMID: 29685386RESULT

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fatih TASKESEN

    Erzincan Binali Yildirim University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Dept. Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 29, 2020

Study Start

January 1, 2017

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)