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Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Primary Purpose

Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hyaluronic Acid
Temporomandibular Joint Arthroscopy
Antibiotic therapy
corticosteroid
Antiinflammatories
Analgesics
Exercise program
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disc Displacement focused on measuring hyaluronic acid, temporomandibular joint arthroscopy, internal derangements, disc displacement, temporomandibular disorders

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital Universitario de La Princesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

arthroscopy

arthroscopy plus hyaluronic Acid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Number of Participants with Treatment Related Adverse Events
any adverse response to the intervention
Symptoms Duration Mean (Months)
symptoms duration mean reported by the participants
Number of Participants with chondromalacia
arthroscopic finding
Number of Participants with synovitis
arthroscopic finding
Irrigation Volume Mean (cc)
average irrigation fluid used during intervention
Number of Participants with Occlusal Stabilization Splint
stabilization splint use reported by the participant
Number of Participants with Osteophyte by magnetic resonance imaging
radiographic finding in jaw condyle
Number of Participants with joint surfaces flattening by magnetic resonance imaging
radiographic finding in jaw condyle or temporal bone
Number of Participants with Subchondral Geode by magnetic resonance imaging
radiographic finding in jaw condyle
Disc Position by magnetic resonance imaging
No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction
Number of Participants with pain in masseter muscle by digital palpation
pain reported by the participant
Number of Participants with pain in Temporal muscle by digital palpation
pain reported by the participant
Number of Participants with pain in Medial Pterygoid Muscle by digital palpation
pain reported by the participant
Number of Participants with pain in digastric Muscle by digital palpation
pain reported by the participant
Number of Participants with pain in Genihyoid Muscle by digital palpation
pain reported by the participant
Number of Participants with pain in Mylohyoid Muscle by digital palpation
pain reported by the participant

Full Information

First Posted
September 23, 2019
Last Updated
September 28, 2019
Sponsor
Universidad Complutense de Madrid
Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Zambon SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04110587
Brief Title
Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
Official Title
Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2013 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Zambon SpA

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders
Keywords
hyaluronic acid, temporomandibular joint arthroscopy, internal derangements, disc displacement, temporomandibular disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arthroscopy
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
arthroscopy plus hyaluronic Acid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Sodium Hyaluronate
Intervention Description
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
Intervention Type
Procedure
Intervention Name(s)
Temporomandibular Joint Arthroscopy
Intervention Description
Lysis and Lavage
Intervention Type
Drug
Intervention Name(s)
Antibiotic therapy
Intervention Description
Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
Intervention Type
Drug
Intervention Name(s)
corticosteroid
Intervention Description
Dexamethasone, 4 mg I.V. (Intraoperative)
Intervention Type
Drug
Intervention Name(s)
Antiinflammatories
Intervention Description
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
Intervention Type
Drug
Intervention Name(s)
Analgesics
Intervention Description
Metamizol 575 mg / 8h by mouth (Post-operatively)
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Home exercise program
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months
Description
Visual Analog Scale 0 to 10. Higher values represent a worse outcome.
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months
Description
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.
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months
Description
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
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment Related Adverse Events
Description
any adverse response to the intervention
Time Frame
From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.
Title
Symptoms Duration Mean (Months)
Description
symptoms duration mean reported by the participants
Time Frame
At baseline
Title
Number of Participants with chondromalacia
Description
arthroscopic finding
Time Frame
During intervention
Title
Number of Participants with synovitis
Description
arthroscopic finding
Time Frame
During intervention
Title
Irrigation Volume Mean (cc)
Description
average irrigation fluid used during intervention
Time Frame
During intervention
Title
Number of Participants with Occlusal Stabilization Splint
Description
stabilization splint use reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with Osteophyte by magnetic resonance imaging
Description
radiographic finding in jaw condyle
Time Frame
At baseline and Month 12.
Title
Number of Participants with joint surfaces flattening by magnetic resonance imaging
Description
radiographic finding in jaw condyle or temporal bone
Time Frame
At baseline and Month 12
Title
Number of Participants with Subchondral Geode by magnetic resonance imaging
Description
radiographic finding in jaw condyle
Time Frame
At baseline and Month 12
Title
Disc Position by magnetic resonance imaging
Description
No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction
Time Frame
At baseline and Month 12
Title
Number of Participants with pain in masseter muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with pain in Temporal muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with pain in Medial Pterygoid Muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with pain in digastric Muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with pain in Genihyoid Muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Title
Number of Participants with pain in Mylohyoid Muscle by digital palpation
Description
pain reported by the participant
Time Frame
From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cano Sánchez
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julian Campo Trapero
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mario Fernando Muñoz Guerra
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Oscar Gabriel Castaño Joaqui
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19114956
Citation
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.
Results Reference
background
PubMed Identifier
8193981
Citation
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
Results Reference
background
PubMed Identifier
12535445
Citation
Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.
Results Reference
background
PubMed Identifier
2923691
Citation
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.
Results Reference
background
PubMed Identifier
32609918
Citation
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.
Results Reference
derived

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Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

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