Occlusal Adjustment as Treatment for Chronic Orofacial Pain
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ClinicalTrials.gov Identifier: NCT00899717 |
Recruitment Status
:
Completed
First Posted
: May 12, 2009
Results First Posted
: July 16, 2013
Last Update Posted
: July 26, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Temporomandibular Joint Disorders Orofacial Pain | Procedure: Occlusal adjustment Procedure: Placebo occlusal adjustment | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Procedure: Occlusal adjustment
modification of occlusal surfaces
Other Names:
|
Placebo Comparator: B |
Procedure: Placebo occlusal adjustment
Simulated modification of occlusal surfaces
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- Visual Analogic Scale for Pain Intensity (0-10) [ Time Frame: Baseline, immediately after therapy, 3 months and 6 months after therapy ]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"
- Symptom Checklist-90-Revised (SCL-90-R®) [ Time Frame: Before and 6 months after therapy ]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 ]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 ]Maximum voluntary unassisted mouth opening
- Condylar Path Angles [ Time Frame: Baseline ]Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899717
Spain | |
Facultad de Medicina y Odontología | |
Santiago de Compostela, La Coruña, Spain, 15782 | |
Complejo Hospitalario Universitario de La Coruña | |
La Coruña, Spain, 15006 |
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 |
Responsible Party: | Urbano Santana, Prof., University of Santiago de Compostela |
ClinicalTrials.gov Identifier: | NCT00899717 History of Changes |
Other Study ID Numbers: |
2009/017 |
First Posted: | May 12, 2009 Key Record Dates |
Results First Posted: | July 16, 2013 |
Last Update Posted: | July 26, 2013 |
Last Verified: | July 2013 |
Keywords provided by Urbano Santana, 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 |