- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817162
Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
April 17, 2023 updated by: Instituto Portugues da Face
Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?
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.
Study Overview
Status
Enrolling by invitation
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lisboa, Portugal, 1050-227
- Instituto Português da Face
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group: PRP
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint
|
Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.
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
Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.
|
Active Comparator: PRP + Ropivacaine
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint
|
Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.
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
Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TMJ Pain
Time Frame: In the first week at a consultation after injection and TMJ arthrocentesis
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General state pre vs post
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
Time Frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
|
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
Time Frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
|
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
Time Frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
|
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
Time Frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
|
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
Time Frame: 1 week after injection and TMJ arthrocentesis in a physiotherapy 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
|
Postoperative pain
Time Frame: Daily 1 week after TMJ arthrocentesis and infiltration
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
April 4, 2023
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Ropivacaine
Other Study ID Numbers
- ROPIVACAINE_TMJ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to data protection policy it is not possible to share this data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Temporomandibular Joint Disorders
-
Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular Disorder | Temporomandibular Joint Pain | Manual Therapy | Temporomandibular Joint Disc DisplacementTurkey
-
TC Erciyes UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Pain | Temporomandibular Joint Osteoarthritis | Temporomandibular Joint EffusionTurkey
-
University of Nove de JulhoUnknownTemporomandibular DisorderBrazil
-
Karolinska InstitutetUniversity of Oslo; University of BergenCompletedTemporomandibular Joint Disorders | Temporomandibular Joint Disc Displacement | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisSweden
-
Hacettepe UniversityKarabuk UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular DisorderTurkey
-
CES UniversityCompletedTemporomandibular Disorder | Children, Only | Pain Disorder | Joint Disorder, Temporomandibular
-
University of L'AquilaUnknownTEMPOROMANDIBULAR JOINT DISEASESItaly
-
Wroclaw Medical UniversityEnrolling by invitationTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisPoland
-
Marmara UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular DisorderTurkey
-
Jagiellonian UniversityCompletedTemporomandibular DisordersPoland
Clinical Trials on temporomandibular joint arthrocentesis
-
Tokat Gaziosmanpasa UniversityCompletedTemporomandibular Joint DisordersTurkey
-
Sohag UniversityRecruitingTemporomandibular Joint DisordersEgypt
-
Istanbul University - Cerrahpasa (IUC)CompletedQuality of Life | Chronic Pain | Sleep | Headache | Temporomandibular Joint Dysfunction | Chronic Migraine, HeadacheTurkey
-
Tokat Gaziosmanpasa UniversityRecruitingPain | Temporomandibular Disorder | Spine | Discomfort | Geriatric IndividualsTurkey
-
University of Sao Paulo General HospitalCompletedTemporomandibular DisordersBrazil
-
Marmara UniversityCompletedTemporomandibular Joint DisordersTurkey
-
Colorado Joint ReplacementRecruitingEffusion JointUnited States
-
Ain Shams UniversityCompletedTMJ - Oral &Maxillofacial SurgeryEgypt
-
Ankara Training and Research HospitalCompletedQuality of Life | Neuropathic Pain | Somatic PainTurkey
-
Cairo UniversityRecruiting