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Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

Not Applicable
Completed
Conditions
Arthrocentesis
Interventions
Procedure: TMJ Arthrocentesis
Registration Number
NCT04367259
Lead Sponsor
Erzincan University
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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Double puncture arthrocentesis (DPA) groupTMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis
Single puncture arthrocentesis (SPA) groupTMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis
Primary Outcome Measures
NameTimeMethod
The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)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 millimetersat 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 Outcome Measures
NameTimeMethod
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 operator rated the degree of easiness of the procedure on a VAS as 0-very easy 10-very difficult to perform.

The rate of treatment tolerability assessed by 5-point Likert-type scale6th month

The degree to which overt adverse effects and post operative complications (pain, feeling of pressure in TMJ area and disturbing sound) can be tolerated by the patient. Patients were asked to rate the tolerability on a 5 point scale as 0- lowest, 4-highest.

Rate of perceived effectiveness of the treatment by using 5-point Likert-type scaleat 6th month

Patients rated the subjective treatment effectiveness on a 5-point scale as 0- lowest, 4 highest values.

Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimetersat 6th month (t4)

Lateral Movement of the mandible towards the affected Temporomandibular joint (LT) was measured as the distance between the midlines of the upper and lower incisors by a caliper while patient's mandible was shifted towards the affected TMJ. Three measurements were performed, and their average is recorded.

The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)at 6th month (t4)

Patients rated their pain level at rest on a Numerical pain Scale (NRS) )(0-10 where 0 is no pain and 10 is the worst pain imaginable)

Measurement of Duration of the Procedure in Minutesat 1st day (At the end of the procedure)

Total time for arthrocentesis was noted at the end of the procedure

The rate of chewing efficiency by using Visual Analog Scale (VAS)at 6th month (t4)

Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.

Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimetersat 6th month (t4)

Lateral Movement of the mandible away from the affected Temporomandibular joint (LA) was measured as the distance between the midlines of the upper and lower incisors by a caliper while patient's mandible was shifted away from the affected TMJ. Three measurements were performed, and their average is recorded.

Measurement of protrusive movement of the mandible in millimetersat 6th month (t4)

Protrusive movement of the mandible was measured as the distance in horizontal direction between the incisal edges of upper and lower incisors by a caliper when mandible moves forward.

Trial Locations

Locations (1)

Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

🇹🇷

Erzincan, Turkey

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