Back to resultsOcclusal Adjustment as Treatment for Chronic Orofacial Pain
Primary Purpose
Temporomandibular Joint Disorders, Orofacial Pain
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Occlusal adjustment
Placebo occlusal adjustment
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint Disorders (TMD), Orofacial pain, Limited mouth opening, Craniomandibular dysfunction syndrome, Axiography, Gnatography, Preferred chewing side, Occlusal adjustment, Selective grinding, Handedness, Bruxism, TMD, Costen's Syndrome, Myofascial pain, TMD treatment, Pain
Eligibility Criteria
Inclusion Criteria:
- People suitable for inclusion in the study are full dentate patients
- Aged between 18 and 65 years
- Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated
Exclusion Criteria:
- Pregnancy
- Trauma
- Previous TMJ surgery
- Patient refusal to consent to participate in the study or significant concerns about the study
- Limited collaboration
- Concurrent active treatment with orthodontics, and active periodontal disease
Sites / Locations
- Facultad de Medicina y Odontología
- Complejo Hospitalario Universitario de La Coruña
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogic Scale for Pain Intensity (0-10)
The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"
Secondary Outcome Measures
Symptom Checklist-90-Revised (SCL-90-R®)
Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Preferred Chewing Side
The change in the habitual chewing side of each participant across the study
Maximum Mouth Opening (mm)
Maximum voluntary unassisted mouth opening
Condylar Path Angles
Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.
Full Information
NCT ID
NCT00899717
First Posted
May 11, 2009
Last Updated
July 21, 2013
Sponsor
University of Santiago de Compostela
1. Study Identification
Unique Protocol Identification Number
NCT00899717
Brief Title
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
Official Title
Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.
Detailed Description
Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Orofacial Pain
Keywords
Temporomandibular Joint Disorders (TMD), Orofacial pain, Limited mouth opening, Craniomandibular dysfunction syndrome, Axiography, Gnatography, Preferred chewing side, Occlusal adjustment, Selective grinding, Handedness, Bruxism, TMD, Costen's Syndrome, Myofascial pain, TMD treatment, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Occlusal adjustment
Other Intervention Name(s)
Selective grinding, Occlusal reshaping, Occlusal equilibration, Occlusal therapy
Intervention Description
modification of occlusal surfaces
Intervention Type
Procedure
Intervention Name(s)
Placebo occlusal adjustment
Intervention Description
Simulated modification of occlusal surfaces
Primary Outcome Measure Information:
Title
Visual Analogic Scale for Pain Intensity (0-10)
Description
The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"
Time Frame
Baseline, immediately after therapy, 3 months and 6 months after therapy
Secondary Outcome Measure Information:
Title
Symptom Checklist-90-Revised (SCL-90-R®)
Description
Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Time Frame
Before and 6 months after therapy
Title
Preferred Chewing Side
Description
The change in the habitual chewing side of each participant across the study
Time Frame
Before and 6 months after therapy
Title
Maximum Mouth Opening (mm)
Description
Maximum voluntary unassisted mouth opening
Time Frame
6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up
Title
Condylar Path Angles
Description
Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People suitable for inclusion in the study are full dentate patients
Aged between 18 and 65 years
Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated
Exclusion Criteria:
Pregnancy
Trauma
Previous TMJ surgery
Patient refusal to consent to participate in the study or significant concerns about the study
Limited collaboration
Concurrent active treatment with orthodontics, and active periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José López-Cedrún Cembranos, MD, DDS, PhD
Organizational Affiliation
Complejo Hospitalario Universitario de La Coruña
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Urbano Santana Penín, MD, DDS, PhD
Organizational Affiliation
Universidad de Santiago de Compostela
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Medicina y Odontología
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15782
Country
Spain
Facility Name
Complejo Hospitalario Universitario de La Coruña
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
12. IPD Sharing Statement
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Occlusal Adjustment as Treatment for Chronic Orofacial Pain
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