Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of temporomandibular joint internal derangements in Wilkes stages III and IV by magnetic resonance imaging
- •Limitation of maximum oral opening or duplication of joint pain by palpation
- •lack of response to conservative therapies
排除标准
- •Any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.)
- •Previous temporomandibular joint surgical treatment: arthrocentesis, arthroscopy or open surgery
- •Infection in Temporomandibular Joint or in puncture site
- •Hyaluronic acid or corticosteroids injection in Temporomandibular Joint in previous 6 months
- •Pregnant or breastfeeding women
- •Participants who refuse to complete the treatment or unavailable to complete the follow-up
研究组 & 干预措施
arthroscopy
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.
干预措施: Temporomandibular Joint Arthroscopy (Procedure)
arthroscopy
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.
干预措施: Antibiotic therapy (Drug)
arthroscopy
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.
干预措施: corticosteroid (Drug)
arthroscopy
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.
干预措施: Antiinflammatories (Drug)
arthroscopy
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.
干预措施: Analgesics (Drug)
arthroscopy
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.
干预措施: Exercise program (Other)
arthroscopy plus hyaluronic Acid
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.
干预措施: Hyaluronic Acid (Biological)
arthroscopy plus hyaluronic Acid
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.
干预措施: Temporomandibular Joint Arthroscopy (Procedure)
arthroscopy plus hyaluronic Acid
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.
干预措施: Antibiotic therapy (Drug)
arthroscopy plus hyaluronic Acid
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.
干预措施: corticosteroid (Drug)
arthroscopy plus hyaluronic Acid
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.
干预措施: Antiinflammatories (Drug)
arthroscopy plus hyaluronic Acid
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.
干预措施: Analgesics (Drug)
arthroscopy plus hyaluronic Acid
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.
干预措施: Exercise program (Other)
结局指标
主要结局
Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months
时间窗: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Visual Analog Scale 0 to 10. Higher values represent a worse outcome.
Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months
时间窗: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
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.
Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months
时间窗: From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.
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
次要结局
- Number of Participants with Osteophyte by magnetic resonance imaging(At baseline and Month 12.)
- Number of Participants with pain in Temporal muscle by digital palpation(From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.)
- Symptoms Duration Mean (Months)(At baseline)
- Number of Participants with chondromalacia(During intervention)
- Irrigation Volume Mean (cc)(During intervention)
- Number of Participants with Treatment Related Adverse Events(From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.)
- Number of Participants with synovitis(During intervention)
- Number of Participants with Occlusal Stabilization Splint(From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.)
- Disc Position by magnetic resonance imaging(At baseline and Month 12)
- Number of Participants with pain in Genihyoid Muscle by digital palpation(From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.)
- Number of Participants with joint surfaces flattening by magnetic resonance imaging(At baseline and Month 12)
- Number of Participants with Subchondral Geode by magnetic resonance imaging(At baseline and Month 12)
- Number of Participants with pain in masseter muscle by digital palpation(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(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(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(From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.)