Clinical trial NCT00899717: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

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

Primary outcomes:
measure: Visual Analogic Scale for Pain Intensity (0-10)
timeFrame: Baseline, immediately after therapy, 3 months and 6 months after therapy
Secondary outcomes:
measure: Symptom Checklist-90-Revised (SCL-90-R®)
timeFrame: Before and 6 months after therapy
measure: Preferred Chewing Side
timeFrame: Before and 6 months after therapy
measure: Maximum Mouth Opening (mm)
timeFrame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up
measure: Condylar Path Angles
timeFrame: Baseline
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Facultad de Medicina y Odontología
state: La Coruña
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario de La Coruña
Study officials:
affiliation: Complejo Hospitalario Universitario de La Coruña
name: José López-Cedrún Cembranos, MD, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Santiago de Compostela
name: Urbano Santana Penín, MD, DDS, PhD
role: STUDY_DIRECTOR
References: