Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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

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

Conditions
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Arthrocentesis

Intervention / Treatment
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* Procedure: TMJ Arthrocentesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single puncture arthrocentesis (SPA) group<br>Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis | Procedure: TMJ Arthrocentesis<br>* Temporomandibular joint arthrocentesis<br>|
| Active Comparator: Double puncture arthrocentesis (DPA) group<br>Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis | Procedure: TMJ Arthrocentesis<br>* Temporomandibular joint arthrocentesis<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular Joint