ArthrocentesisNCT04367259
Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis
A study testing TMJ Arthrocentesis in people with Arthrocentesis, run by Erzincan University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthrocentesis
- What is being tested?
- TMJ Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
- Restricted mouth opening
Who cannot join
- History of systemic disease effecting TMJ.
- History of previous TMJ surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi
Erzincan
About this study
Official title: 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).
Read the 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.
- Conditions
- Arthrocentesis
- Being tested
- TMJ Arthrocentesis
- Keywords
- Temporomandibular Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ ArthrocentesisProcedure or surgery
Temporomandibular joint arthrocentesis
| Study group | Role | What they receive |
|---|---|---|
| Single puncture arthrocentesis (SPA) group | Active comparator | Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis Receives: Procedure: TMJ Arthrocentesis |
| Double puncture arthrocentesis (DPA) group | Active comparator | Patients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis Receives: Procedure: TMJ Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 6th month (t4)
Secondary outcomes (31)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 6th month (t4)
Measurement of Duration of the Procedure in Minutes
Total time for arthrocentesis was noted at the end of the procedure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 6th month (t4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jan 2017
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthrocentesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih TASKESEN, Erzincan University
- Investigators
- Fatih TASKESEN, Study chair, Erzincan Binali Yildirim University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367259
- Sponsor's protocol ID
- 135163
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31021311Senturk 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.
PubMed 29685386
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of Temporomandibular Joint Disc Displacement Without Reduction
- ClinicalTrials.gov ID
- NCT04367259
- Acronym / sponsor ID
- 135163
- Conditions
- Arthrocentesis
- Keywords
- Temporomandibular Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single puncture arthrocentesis (SPA) group | Active comparator | Procedure: TMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with single puncture arthrocentesis |
| Double puncture arthrocentesis (DPA) group | Active comparator | Procedure: TMJ ArthrocentesisPatients presenting temporomandibular joint disc displacement without reduction (DDwoR) treated with double puncture arthrocentesis |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
- Restricted mouth opening
Key exclusion criteria (2 listed)
- History of systemic disease effecting TMJ.
- History of previous TMJ surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMJ ArthrocentesisTemporomandibular joint arthrocentesis | Procedure or surgery | Double puncture arthrocentesis (DPA) group, Single puncture arthrocentesis (SPA) group |
Primary outcome
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
31 secondary outcomes
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
Time frame: At Baseline (t0)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
Time frame: at 1st week (t1)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
Time frame: at 1st month (t2)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
Time frame: at 3rd month (t3)
The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)
Time frame: at 6th month (t4)
Measurement of Duration of the Procedure in Minutes
Time frame: 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)
Time frame: at 1st day (At the end of the procedure)
The rate of treatment tolerability assessed by 5-point Likert-type scale
Time frame: 1st day
The rate of treatment tolerability assessed by 5-point Likert-type scale
Time frame: 1st week
The rate of treatment tolerability assessed by 5-point Likert-type scale
Time frame: 6th month
The rate of chewing efficiency by using Visual Analog Scale (VAS)
Time frame: at baseline (t0)
The rate of chewing efficiency by using Visual Analog Scale (VAS)
Time frame: at 1st week (t1)
The rate of chewing efficiency by using Visual Analog Scale (VAS)
Time frame: at 1st month (t2)
The rate of chewing efficiency by using Visual Analog Scale (VAS)
Time frame: at 3rd month (t3)
The rate of chewing efficiency by using Visual Analog Scale (VAS)
Time frame: at 6th month (t4)
Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale
Time frame: at 6th month
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at baseline (t0)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 1st week (t1)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 1st month (t2)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 3rd month (t3)
Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 6th month (t4)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at baseline (t0)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 1st week (t1)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 1st month (t2)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 3rd month (t3)
Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters
Time frame: at 6th month (t4)
Measurement of protrusive movement of the mandible in millimeters
Time frame: at baseline (t0)
Measurement of protrusive movement of the mandible in millimeters
Time frame: at 1st week (t1)
Measurement of protrusive movement of the mandible in millimeters
Time frame: at 1st month (t2)
Measurement of protrusive movement of the mandible in millimeters
Time frame: at 3rd month (t3)
Measurement of protrusive movement of the mandible in millimeters
Time frame: at 6th month (t4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Results publication: PubMed 31021311Bayramoglu 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.
- Results publication: PubMed 29685386Senturk 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.
- Individual participant dataSharing planned: No
Related trials for Arthrocentesis
Active, not recruiting
Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement
Temporomandibular Joint Internal Derangement
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
Recruiting
TMJ Arthroscopy Compared to Arthrocentesis in Disc Displacement Without Reduction
Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disc Displacement, Without Reduction
Not yet recruitingObservational study
MASSETER MUSCLE EVALUATION AFTER TEMPOROMANDIBULAR JOINT ARTHROCENTESIS
Temporomandibular Joint Dysfunction
Not yet recruiting
Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih TASKESEN study chair
Erzincan Binali Yildirim University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ Arthrocentesis in people with Arthrocentesis, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS) (time frame: baseline (t0)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.