Occlusal Adjustment as Treatment for Chronic Orofacial Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Temporomandibular Joint Disorders Orofacial Pain	Procedure: Occlusal adjustment Procedure: Placebo occlusal adjustment	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Temporomandibular Joint Dysfunction

Drug Information available for: Salicylic acid

U.S. FDA Resources

Further study details as provided by University of Santiago de Compostela:

Primary Outcome Measures:

Visual Analogic Scale for Pain Intensity (0-10) [ Time Frame: Baseline, immediately after therapy, 3 months and 6 months after therapy ] [ Designated as safety issue: No ]
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®) [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Preferred Chewing Side [ Time Frame: Before and 6 months after therapy ] [ Designated as safety issue: No ]
The change in the habitual chewing side of each participant across the study
Maximum Mouth Opening (mm) [ Time Frame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up ] [ Designated as safety issue: No ]
Maximum voluntary unassisted mouth opening
Condylar Path Angles [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.


Enrollment:	21
Study Start Date:	May 2009
Study Completion Date:	April 2010
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Procedure: Occlusal adjustment modification of occlusal surfaces Other Names: Selective grinding Occlusal reshaping Occlusal equilibration Occlusal therapy
Placebo Comparator: B	Procedure: Placebo occlusal adjustment Simulated modification of occlusal surfaces

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."

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899717

Locations


Spain
Facultad de Medicina y Odontología
Santiago de Compostela, La Coruña, Spain, 15782
Complejo Hospitalario Universitario de La Coruña
La Coruña, Spain, 15006

Sponsors and Collaborators

University of Santiago de Compostela

Investigators


Principal Investigator:	José López-Cedrún Cembranos, MD, DDS, PhD	Complejo Hospitalario Universitario de La Coruña
Study Director:	Urbano Santana Penín, MD, DDS, PhD	Universidad de Santiago de Compostela

More Information


Responsible Party:	Urbano Santana, Prof., University of Santiago de Compostela
ClinicalTrials.gov Identifier:	NCT00899717 History of Changes
Other Study ID Numbers:	2009/017
Study First Received:	May 11, 2009
Results First Received:	April 10, 2013
Last Updated:	July 21, 2013
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Santiago de Compostela:


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

Additional relevant MeSH terms:


Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Facial Pain Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases	Myofascial Pain Syndromes Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Salicylic Acid Anti-Infective Agents Antifungal Agents Keratolytic Agents Dermatologic Agents

ClinicalTrials.gov processed this record on September 26, 2016