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| Name | Class |
|---|---|
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Zambon SpA | INDUSTRY |
This study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. A participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. Hypothesis: hyaluronic acid as an adjunct in temporomandibular joint arthroscopic surgery provides additional benefits in clinical and radiological outcomes in temporomandibular joint internal derangements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arthroscopy | Placebo Comparator | Temporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative. |
|
| arthroscopy plus hyaluronic Acid | Active Comparator | Temporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative. An hyaluronic acid injection of 1 mL (Durolane®, 20 mg / mL, Zambon, Barcelona, Spain) at the end of arthroscopy that was only performed in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid | Biological | 1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months | Visual Analog Scale 0 to 10. Higher values represent a worse outcome. | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months | measured from edge of upper central incisor to edge of lower antagonist incisor. Range scale 0 to 60 (mm). Higher values represent a better outcome. | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months | OHIP-14sp questionnaire total average score to measure Oral Health-Related Quality of Life. Range scale 0 to 56. Higher values represent a worse outcome. Total average score is calculated by adding the score of each question and dividing by 14 | From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Related Adverse Events | any adverse response to the intervention | From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12. |
| Symptoms Duration Mean (Months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Cano Sánchez | Universidad Complutense de Madrid | Study Director |
| Julian Campo Trapero | Universidad Complutense de Madrid | Study Director |
| Mario Fernando Muñoz Guerra | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Study Director |
| Oscar Gabriel Castaño Joaqui | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19114956 | Background | Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50. | |
| 8193981 | Background | Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. |
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Treatment allocation was concealed from participants and examiner (using sealed and numbered opaque envelopes by the research coordinator), and the data analyst (by encoded data).
| Temporomandibular Joint Arthroscopy | Procedure | Lysis and Lavage |
|
| Antibiotic therapy | Drug | Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative). |
|
| corticosteroid | Drug | Dexamethasone, 4 mg I.V. (Intraoperative) |
|
| Antiinflammatories | Drug | Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively). |
|
| Analgesics | Drug | Metamizol 575 mg / 8h by mouth (Post-operatively) |
|
| Exercise program | Other | Home exercise program |
|
symptoms duration mean reported by the participants |
| At baseline |
| Number of Participants with chondromalacia | arthroscopic finding | During intervention |
| Number of Participants with synovitis | arthroscopic finding | During intervention |
| Irrigation Volume Mean (cc) | average irrigation fluid used during intervention | During intervention |
| Number of Participants with Occlusal Stabilization Splint | stabilization splint use reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with Osteophyte by magnetic resonance imaging | radiographic finding in jaw condyle | At baseline and Month 12. |
| Number of Participants with joint surfaces flattening by magnetic resonance imaging | radiographic finding in jaw condyle or temporal bone | At baseline and Month 12 |
| Number of Participants with Subchondral Geode by magnetic resonance imaging | radiographic finding in jaw condyle | At baseline and Month 12 |
| Disc Position by magnetic resonance imaging | No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction | At baseline and Month 12 |
| Number of Participants with pain in masseter muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with pain in Temporal muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with pain in Medial Pterygoid Muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with pain in digastric Muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with pain in Genihyoid Muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| Number of Participants with pain in Mylohyoid Muscle by digital palpation | pain reported by the participant | From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. |
| 12535445 | Background | Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970. |
| 2923691 | Background | Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. doi: 10.1001/archotol.1989.01860280067019. |
| 32609918 | Derived | Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25. |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D000890 | Anti-Infective Agents |
| D000305 | Adrenal Cortex Hormones |
| D000893 | Anti-Inflammatory Agents |
| D000700 | Analgesics |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D002491 | Central Nervous System Agents |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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