Clinical trial NCT04367259: Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis
Official title: Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of Temporomandibular Joint Disc Displacement Without Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthrocentesis
Keywords: Temporomandibular Joint
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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.

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

Primary outcomes:
measure: The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
timeFrame: baseline (t0)
measure: The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
timeFrame: At 1st week (t1)
measure: The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
timeFrame: at 1st month (t2)
measure: The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
timeFrame: at 3rd month (t3)
measure: The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
timeFrame: at 6th month (t4)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: baseline (t0)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: at 1st week (t1)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: at 1st month (t2)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: at 3rd month (t3)
measure: The measurement of pain-free maximum mouth opening (MMO) in millimeters
timeFrame: at 6th month (t4)
Secondary outcomes:
measure: The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
timeFrame: At Baseline (t0)
measure: The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
timeFrame: at 1st week (t1)
measure: The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
timeFrame: at 1st month (t2)
measure: The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
timeFrame: at 3rd month (t3)
measure: The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
timeFrame: at 6th month (t4)
measure: Measurement of Duration of the Procedure in Minutes
timeFrame: at 1st day (At the end of the procedure)
measure: Measurement of the easiness of the procedure to the operator by using Visual Analog Scale (VAS)
timeFrame: at 1st day (At the end of the procedure)
measure: The rate of treatment tolerability assessed by 5-point Likert-type scale
timeFrame: 1st day
measure: The rate of treatment tolerability assessed by 5-point Likert-type scale
timeFrame: 1st week
measure: The rate of treatment tolerability assessed by 5-point Likert-type scale
timeFrame: 6th month
measure: The rate of chewing efficiency by using Visual Analog Scale (VAS)
timeFrame: at baseline (t0)
measure: The rate of chewing efficiency by using Visual Analog Scale (VAS)
timeFrame: at 1st week (t1)
measure: The rate of chewing efficiency by using Visual Analog Scale (VAS)
timeFrame: at 1st month (t2)
measure: The rate of chewing efficiency by using Visual Analog Scale (VAS)
timeFrame: at 3rd month (t3)
measure: The rate of chewing efficiency by using Visual Analog Scale (VAS)
timeFrame: at 6th month (t4)
measure: Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale
timeFrame: at 6th month
measure: Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at baseline (t0)
measure: Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 1st week (t1)
measure: Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 1st month (t2)
measure: Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 3rd month (t3)
measure: Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 6th month (t4)
measure: Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at baseline (t0)
measure: Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 1st week (t1)
measure: Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 1st month (t2)
measure: Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 3rd month (t3)
measure: Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
timeFrame: at 6th month (t4)
measure: Measurement of protrusive movement of the mandible in millimeters
timeFrame: at baseline (t0)
measure: Measurement of protrusive movement of the mandible in millimeters
timeFrame: at 1st week (t1)
measure: Measurement of protrusive movement of the mandible in millimeters
timeFrame: at 1st month (t2)
measure: Measurement of protrusive movement of the mandible in millimeters
timeFrame: at 3rd month (t3)
measure: Measurement of protrusive movement of the mandible in millimeters
timeFrame: at 6th month (t4)
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi
Study officials:
affiliation: Erzincan Binali Yildirim University Faculty of Dentistry
name: Fatih TASKESEN
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.