Phase 2
N=21
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
Temporomandibular Joint Disorders · Orofacial Pain
Bottom Line
View on ClinicalTrials.gov: NCT00899717 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Visual Analogic Scale for Pain Intensity (0-10) — 6.52; 4.8; .81; 2.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Occlusal adjustment (Procedure); Placebo occlusal adjustment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Santiago de Compostela
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogic Scale for Pain Intensity (0-10) |
6.52; 4.8; .81; 2.05; 2.25; 3.80 | — |
| SECONDARY Symptom Checklist-90-Revised (SCL-90-R®) |
1.32; 0.58; 0.75; 0.51 | — |
| SECONDARY Preferred Chewing Side |
0; 0; 8; 1 | — |
| SECONDARY Maximum Mouth Opening (mm) |
41.6; 42.36; 45.50; 45.07; 47.10; 41.27 | — |
| SECONDARY Condylar Path Angles |
52.33; 49; 49.20; 48.27; 56.75; 51.09 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00899717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.