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Completed

NCT Number: NCT04367259

Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis

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).

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Key information

Conditions

Arthrocentesis

Age range

21 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

Erzincan, Turkey (Türkiye)

About this study

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 At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMJ Arthrocentesis

Procedure

Temporomandibular joint arthrocentesis

Primary outcomes

  1. The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Time frame: baseline (t0)

    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)

  2. The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Time frame: At 1st week (t1)

    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)

  3. The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Time frame: at 1st month (t2)

    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)

  4. The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Time frame: at 3rd month (t3)

    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)

  5. The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)

    Time frame: 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)

  6. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Time frame: baseline (t0)

    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.

  7. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Time frame: at 1st week (t1)

    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.

  8. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Time frame: at 1st month (t2)

    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.

  9. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Time frame: at 3rd month (t3)

    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.

  10. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Time frame: at 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 outcomes

  1. The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    Time frame: At Baseline (t0)

    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)

  2. The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    Time frame: at 1st week (t1)

    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)

  3. The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    Time frame: at 1st month (t2)

    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)

  4. The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    Time frame: at 3rd month (t3)

    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)

  5. The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)

    Time frame: 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)

  6. Measurement of Duration of the Procedure in Minutes

    Time frame: at 1st day (At the end of the procedure)

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

  7. Measurement of the easiness of the procedure to the operator by using Visual Analog Scale (VAS)

    Time frame: 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.

  8. The rate of treatment tolerability assessed by 5-point Likert-type scale

    Time frame: 1st day

    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.

  9. The rate of treatment tolerability assessed by 5-point Likert-type scale

    Time frame: 1st week

    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.

  10. The rate of treatment tolerability assessed by 5-point Likert-type scale

    Time frame: 6th 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.

  11. The rate of chewing efficiency by using Visual Analog Scale (VAS)

    Time frame: at baseline (t0)

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

  12. The rate of chewing efficiency by using Visual Analog Scale (VAS)

    Time frame: at 1st week (t1)

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

  13. The rate of chewing efficiency by using Visual Analog Scale (VAS)

    Time frame: at 1st month (t2)

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

  14. The rate of chewing efficiency by using Visual Analog Scale (VAS)

    Time frame: at 3rd month (t3)

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

  15. The rate of chewing efficiency by using Visual Analog Scale (VAS)

    Time frame: 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.

  16. Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale

    Time frame: at 6th month

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

  17. Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at baseline (t0)

    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.

  18. Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 1st week (t1)

    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.

  19. Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 1st month (t2)

    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.

  20. Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 3rd month (t3)

    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.

  21. Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 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.

  22. Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at baseline (t0)

    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.

  23. Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 1st week (t1)

    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.

  24. Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 1st month (t2)

    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.

  25. Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 3rd month (t3)

    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.

  26. Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters

    Time frame: at 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.

  27. Measurement of protrusive movement of the mandible in millimeters

    Time frame: at baseline (t0)

    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.

  28. Measurement of protrusive movement of the mandible in millimeters

    Time frame: at 1st week (t1)

    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.

  29. Measurement of protrusive movement of the mandible in millimeters

    Time frame: at 1st month (t2)

    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.

  30. Measurement of protrusive movement of the mandible in millimeters

    Time frame: at 3rd month (t3)

    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.

  31. Measurement of protrusive movement of the mandible in millimeters

    Time frame: at 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.

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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