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The infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. PRP is an autologous concentrate of platelets and growth factors, derived from centrifugated blood. Several studies have described the benefits of PRP: it enhances wound healing because of the presence of cytokines and growth factors, and is also stimulates chondrocytes to biosynthesis of collagen. Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the motor ones. The main goal of this investigation is to test the benefits of adding Ropivacaine to the infiltration of PRP in patients submitted to TMJ arthrocentesis.
To investigate the potential reduction of pain in the postoperative week in patients submitted to temporomandibular joint double portal arthrocentesis with lavage and Platelet Rich Plasma (PRP) the authors designed a double-blind randomized clinical trial, comparing a treatment group with additional ropivacaine and a control group without ropivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group: PRP | Placebo Comparator | Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint |
|
| PRP + Ropivacaine | Active Comparator | Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection | Drug | Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the without affecting the motor ones. Ropivacaine comes as solution for injection. |
| Measure | Description | Time Frame |
|---|---|---|
| TMJ Pain | Change in TMJ pain in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) assessed by the surgeon | In the first week at a consultation after injection and TMJ arthrocentesis |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Change in TMJ pain / TMJ muscles pain: measured by the patient using a Visual Analogue scale (VAS), with a range from 0 to 10, with 0 being no pain and 10 having maximum unbearable pain. VAS score will be measured every day before TMJ arthrocentesis in the week after surgery. | Daily 1 week after TMJ arthrocentesis and infiltration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Português da Face | Lisbon | 1050-227 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34299024 | Background | Derwich M, Mitus-Kenig M, Pawlowska E. Mechanisms of Action and Efficacy of Hyaluronic Acid, Corticosteroids and Platelet-Rich Plasma in the Treatment of Temporomandibular Joint Osteoarthritis-A Systematic Review. Int J Mol Sci. 2021 Jul 9;22(14):7405. doi: 10.3390/ijms22147405. | |
| 33356547 | Background | Keyser C, Bhashyam A, Abdurrob A, Smith JT, Bluman E, Chiodo C. Excess Opioid Disposal Following Orthopaedic Surgery: A Randomized Clinical Trial. Foot Ankle Spec. 2022 Dec;15(6):545-550. doi: 10.1177/1938640020980921. Epub 2020 Dec 27. |
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Due to data protection policy it is not possible to share this data with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2023 | Apr 4, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000069237 | Arthrocentesis |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for PRP and 15 for PRP + Ropivacaine. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthrocentesis.
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The distribution of intervention is performed by attributing a code for each patient. Each code will have been previously distributed randomly between PRP + Ropicavaine and PRP only. The codes are kept closed singularly in an envelope. Before treatment, the nurse will ask the patient to choose an envelope. At this moment, the envelope is placed on a table, and the patient writes his name. Alone, the nurse opens the envelope and sees the code and the indication of PRP or PRP + Ropivacaine. Then, she will prepare, in her room, isolated from the whole team, one 3cc syringe with PRP or PRP + 1cc ropivacaine (7.5mg/ml), depending on the code. Once the code is attributed to the patient, she will deliver a tray with the prepared syringe for treatment. After finishing the arthrocentesis, the doctor injects the chosen treatment. Daily for one week, the patient answers a questionnaire, and at the end of the postoperative week, each patient will be blinded evaluated with a clinical examination.
|
| temporomandibular joint arthrocentesis | Procedure | Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. |
|
| PRP injection | Drug | Platelet-Rich Plasma (PRP) is an orthobiological adjuvant treatment. PRP has properties to restore intra-articular hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis and balances joint angiogenesis. It is often used as a viscosupplement in TMJ arthrocentesis |
|
| Ringer's Lactate solution | Drug | Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon. |
|
| General state pre vs post | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week. (0-much better, 1-litte better, 2-no changes, 3-litter worse, 4-much worse) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Functional limitation chewing foods | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Difficulty closing and mouth opening | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| TMJ pain, muscular pain, ear pain | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Interrupt meals | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Sleep been interrupted | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Difficult doing usual jobs | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Unable to work full capacity | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Difficult to relax | Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often) | Daily 1 week after TMJ arthrocentesis and infiltration |
| Need of medication after intervention | Indication of the number of SOS analgesic pills taken each day | Daily 1 week after TMJ arthrocentesis and infiltration |
| TMJ pain assessed by the physiotherapist | Pain in left and right TMJ evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation |
| TMJ pain during lateral deviation assessed by the physiotherapist | Pain in left and right TMJ during lateral deviation evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation |
| TMJ pain during protrusion assessed by the physiotherapist | TMJ pain during protrusion evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation |
| Myalgia degree assessed by the physiotherapist | Myalgia degree in right and left masseter and temporalis muscles evaluated by the physiotherapist in a 0-3 scale | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation |
| Physiotherapist's perception of comfort during the consultation | For the therapist: in a 0 to 10 scale evaluate your perception of patients comfort during the physical therapy question | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation |
| 33232658 | Background | Rao TN, Goswami D, Roychoudhury A, Bhutia O, Baidya DK, Trikha A. Efficacy of Local Anesthetic Wound Infiltration in Temporomandibular Joint Ankylosis Surgery for Control of Postoperative Pain: A Prospective, Randomized Controlled, and Double-Blinded Trial. J Oral Maxillofac Surg. 2021 Mar;79(3):559.e1-559.e11. doi: 10.1016/j.joms.2020.10.034. Epub 2020 Oct 29. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D000588 |
| Amines |
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |