Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

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

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).

Study Overview

• Status: Completed
• Conditions: Arthrocentesis
• Intervention / Treatment: Procedure: TMJ Arthrocentesis

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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzincan, Turkey
    • Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Single puncture arthrocentesis (SPA) group; Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis	Procedure: TMJ Arthrocentesis; Temporomandibular joint arthrocentesis
ACTIVE_COMPARATOR: Double puncture arthrocentesis (DPA) group; Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis	Procedure: TMJ Arthrocentesis; Temporomandibular joint arthrocentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)	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)	At Baseline (t0)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)	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)	at 1st week (t1)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)	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)	at 1st month (t2)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)	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)	at 3rd month (t3)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)	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)	at 6th month (t4)
Measurement of Duration of the Procedure in Minutes	Total time for arthrocentesis was noted at the end of the procedure	at 1st day (At the end of the procedure)
Measurement of the easiness of the procedure to the operator by using Visual Analog Scale (VAS)	The operator rated the degree of easiness of the procedure on a VAS as 0-very easy 10-very difficult to perform.	at 1st day (At the end of the procedure)
The rate of treatment tolerability assessed by 5-point Likert-type scale	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.	1st day
The rate of treatment tolerability assessed by 5-point Likert-type scale	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.	1st week
The rate of treatment tolerability assessed by 5-point Likert-type scale	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.	6th month
The rate of chewing efficiency by using Visual Analog Scale (VAS)	Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.	at baseline (t0)
The rate of chewing efficiency by using Visual Analog Scale (VAS)	Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.	at 1st week (t1)
The rate of chewing efficiency by using Visual Analog Scale (VAS)	Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.	at 1st month (t2)
The rate of chewing efficiency by using Visual Analog Scale (VAS)	Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.	at 3rd month (t3)
The rate of chewing efficiency by using Visual Analog Scale (VAS)	Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any solid-food.	at 6th month (t4)
Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale	Patients rated the subjective treatment effectiveness on a 5-point scale as 0- lowest, 4 highest values.	at 6th month
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters	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.	at baseline (t0)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters	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.	at 1st week (t1)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters	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.	at 1st month (t2)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters	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.	at 3rd month (t3)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters	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.	at 6th month (t4)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters	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.	at baseline (t0)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters	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.	at 1st week (t1)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters	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.	at 1st month (t2)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters	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.	at 3rd month (t3)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters	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.	at 6th month (t4)
Measurement of protrusive movement of the mandible in millimeters	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.	at baseline (t0)
Measurement of protrusive movement of the mandible in millimeters	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.	at 1st week (t1)
Measurement of protrusive movement of the mandible in millimeters	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.	at 1st month (t2)
Measurement of protrusive movement of the mandible in millimeters	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.	at 3rd month (t3)
Measurement of protrusive movement of the mandible in millimeters	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.	at 6th month (t4)

Collaborators and Investigators

• Sponsor: Erzincan University
• Investigators: Study Chair: Fatih TASKESEN, Erzincan Binali Yildirim University Faculty of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Temporomandibular Joint
• Other Study ID Numbers: 135163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No