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Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP

Primary Purpose

Temporomandibular Joint Disorders

Status
Enrolling by invitation
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Ropivacaine injection
temporomandibular joint arthrocentesis
PRP injection
Ringer's Lactate solution
Sponsored by
Instituto Portugues da Face
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female subjects between the ages of 18-99 years; For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study; In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question; The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures; Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder; Magnetic resonance imaging (MRI) assessing the intra-articular derangement; Radiological findings that most components of the joint were salvageable; Dimitroulis classification between 2 and 3. Exclusion Criteria: Subject has had other previous minimally invasive or invasive treatment for TMD; Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin; Subject has a history of allergy to any drug in the study; Subject taking analgesic medication prior to treatment for other conditions; The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire; Women who are pregnant or breastfeeding. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to the first visit is required (Combined oral contraceptive pill, vaginal ring, male and female condom, intrauterine device, diaphragm, injectable hormonal contraceptive) and agreement to use such a method during study participation. Subjects under 18 and over 99 years old; Subjects diagnosed with the following conditions cannot participate in the study: cardiovascular disorders, peripheral vascular disease, arrhythmias, auriculoventricular conduction disorders, heart failure; hypotension, epileptic patients, patients with liver and kidney disease, patients with porphyria, patients with acidosis. Subjects with severe medical problems and mental illness.

Sites / Locations

  • Instituto Português da Face

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Group: PRP

PRP + Ropivacaine

Arm Description

Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint

Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
Need of medication after intervention
Indication of the number of SOS analgesic pills taken each day
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)
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)
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)
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
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

Full Information

First Posted
April 4, 2023
Last Updated
April 17, 2023
Sponsor
Instituto Portugues da Face
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1. Study Identification

Unique Protocol Identification Number
NCT05817162
Brief Title
Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
Official Title
Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Portugues da Face

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group: PRP
Arm Type
Placebo Comparator
Arm Description
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint
Arm Title
PRP + Ropivacaine
Arm Type
Active Comparator
Arm Description
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
temporomandibular joint arthrocentesis
Intervention Description
Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.
Intervention Type
Drug
Intervention Name(s)
PRP injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ringer's Lactate solution
Intervention Description
Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.
Primary Outcome Measure Information:
Title
TMJ Pain
Description
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
Time Frame
In the first week at a consultation after injection and TMJ arthrocentesis
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
General state pre vs post
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Functional limitation chewing foods
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Difficulty closing and mouth opening
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
TMJ pain, muscular pain, ear pain
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Interrupt meals
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Sleep been interrupted
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Difficult doing usual jobs
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Unable to work full capacity
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Difficult to relax
Description
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)
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
Need of medication after intervention
Description
Indication of the number of SOS analgesic pills taken each day
Time Frame
Daily 1 week after TMJ arthrocentesis and infiltration
Title
TMJ pain assessed by the physiotherapist
Description
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)
Time Frame
1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Title
TMJ pain during lateral deviation assessed by the physiotherapist
Description
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)
Time Frame
1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Title
TMJ pain during protrusion assessed by the physiotherapist
Description
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)
Time Frame
1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Title
Myalgia degree assessed by the physiotherapist
Description
Myalgia degree in right and left masseter and temporalis muscles evaluated by the physiotherapist in a 0-3 scale
Time Frame
1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Title
Physiotherapist's perception of comfort during the consultation
Description
For the therapist: in a 0 to 10 scale evaluate your perception of patients comfort during the physical therapy question
Time Frame
1 week after injection and TMJ arthrocentesis in a physiotherapy consultation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects between the ages of 18-99 years; For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study; In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question; The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures; Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder; Magnetic resonance imaging (MRI) assessing the intra-articular derangement; Radiological findings that most components of the joint were salvageable; Dimitroulis classification between 2 and 3. Exclusion Criteria: Subject has had other previous minimally invasive or invasive treatment for TMD; Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin; Subject has a history of allergy to any drug in the study; Subject taking analgesic medication prior to treatment for other conditions; The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire; Women who are pregnant or breastfeeding. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to the first visit is required (Combined oral contraceptive pill, vaginal ring, male and female condom, intrauterine device, diaphragm, injectable hormonal contraceptive) and agreement to use such a method during study participation. Subjects under 18 and over 99 years old; Subjects diagnosed with the following conditions cannot participate in the study: cardiovascular disorders, peripheral vascular disease, arrhythmias, auriculoventricular conduction disorders, heart failure; hypotension, epileptic patients, patients with liver and kidney disease, patients with porphyria, patients with acidosis. Subjects with severe medical problems and mental illness.
Facility Information:
Facility Name
Instituto Português da Face
City
Lisboa
ZIP/Postal Code
1050-227
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to data protection policy it is not possible to share this data with other researchers.
Citations:
PubMed Identifier
34299024
Citation
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.
Results Reference
background
PubMed Identifier
33356547
Citation
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.
Results Reference
background
PubMed Identifier
33232658
Citation
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.
Results Reference
background

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Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP

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