Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

Arthrocentesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367259
• Other study ID #: 135163
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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

• Status: Completed
• Enrollment: 36
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthrocentesis

Intervention

Procedure:
• TMJ Arthrocentesis
Temporomandibular joint arthrocentesis

Locations

Country	Name	City	State
Turkey	Erzincan Agiz Ve Dis Sagligi Egt Aras Hastanesi	Erzincan

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & 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. 2019 Apr 25:1-6. doi: 10.1080/08869634.2019.1603796. [Epub ahead of print] — View Citation

Sentürk 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)