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Clinical Trials/NCT04367259
NCT04367259
Completed
Not Applicable

Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of Temporomandibular Joint Disc Displacement Without Reduction

Erzincan University1 site in 1 country36 target enrollmentJanuary 1, 2017
ConditionsArthrocentesis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthrocentesis
Sponsor
Erzincan University
Enrollment
36
Locations
1
Primary Endpoint
The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
Status
Completed
Last Updated
6 years ago

Overview

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).

Detailed Description

Study sample consisted of 36 patients with DDwoR. 18 patients received SPA procedure and included in SPA group. The other 18 patients received DPA procedure and included in DPA group. Double puncture arthrocentesis technique: Posterior puncture method was used as described by Alkan and Etoz. for DPA. A straight line was drawn with a marker pen along the skin from the middle portion of the auricular tragus to the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local anesthesia, upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution by inserting two 21- gauge needle. At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle. Single Puncture Arthrocentesis Technique: SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The first reference point in DPA was used as the needle entry point fort he SPA. With this technique, the inflow and outflow of solution were provided through the same cannula and lumen of one 21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of RL solution under high pressure. At the end of the procedure1 mL of SH was injected through the needle.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatih TASKESEN

Head of Dept. Oral and Maxillofacial Surgery

Erzincan University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
  • Restricted mouth opening
  • Exclusion criteria:
  • History of systemic disease effecting TMJ.
  • History of previous TMJ surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: at 6th month (t4)

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)

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

Time Frame: at 6th month (t4)

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.

Secondary Outcomes

  • Measurement of the easiness of the procedure to the operator by using Visual Analog Scale (VAS)(at 1st day (At the end of the procedure))
  • The rate of treatment tolerability assessed by 5-point Likert-type scale(6th month)
  • Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale(at 6th month)
  • Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters(at 6th month (t4))
  • The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)(at 6th month (t4))
  • Measurement of Duration of the Procedure in Minutes(at 1st day (At the end of the procedure))
  • The rate of chewing efficiency by using Visual Analog Scale (VAS)(at 6th month (t4))
  • Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters(at 6th month (t4))
  • Measurement of protrusive movement of the mandible in millimeters(at 6th month (t4))

Study Sites (1)

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