Temporomandibular Joint DisordersPhase 1/2NCT00899717
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
A Phase 1/2 study testing Occlusal adjustment in people with Temporomandibular Joint Disorders and Orofacial Pain, run by University of Santiago de Compostela at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Orofacial Pain
- What is being tested?
- Occlusal adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesSpain
- Study dates
- May 2009to Apr 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario Universitario de La Coruña
A Coruña, La Coruña, 15006
Facultad de Medicina y Odontología
Santiago de Compostela, La Coruña, 15782
About this study
Official title: Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study
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.
Read the 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."
- Conditions
- Temporomandibular Joint Disorders, Orofacial Pain
- Being tested
- Occlusal adjustment, Placebo occlusal adjustment
- 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
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal adjustmentProcedure or surgery
Also called Selective grinding, Occlusal reshaping, Occlusal equilibration, Occlusal therapy
modification of occlusal surfaces
Placebo occlusal adjustmentProcedure or surgery
Simulated modification of occlusal surfaces
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Occlusal adjustment |
| B | Placebo comparator | Not described Receives: Procedure: Placebo occlusal adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Baseline, immediately after therapy, 3 months and 6 months after therapy
Secondary outcomes (4)
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.
Measured: Before and 6 months after therapy
Preferred Chewing Side
The change in the habitual chewing side of each participant across the study
Measured: Before and 6 months after therapy
Maximum Mouth Opening (mm)
Maximum voluntary unassisted mouth opening
Measured: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up
Condylar Path Angles
Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urbano Santana, University of Santiago de Compostela
- Investigators
- José López-Cedrún Cembranos, MD, DDS, PhD, Principal investigator, Complejo Hospitalario Universitario de La CoruñaUrbano Santana Penín, MD, DDS, PhD, Study director, Universidad de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899717
- Sponsor's protocol ID
- 2009/017
- Status last verified
- Jul 2013
- First submitted
- 11 May 2009
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study
- ClinicalTrials.gov ID
- NCT00899717
- Acronym / sponsor ID
- 2009/017
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 16 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Occlusal adjustment |
| B | Placebo comparator | Procedure: Placebo occlusal adjustment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Trauma
- Previous TMJ surgery
- Patient refusal to consent to participate in the study or significant concerns about the study
- Limited collaboration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal adjustmentAlso: Selective grinding, Occlusal reshaping, Occlusal equilibration, Occlusal therapymodification of occlusal surfaces | Procedure or surgery | A |
| Placebo occlusal adjustmentSimulated modification of occlusal surfaces | Procedure or surgery | B |
Primary outcome
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"
4 secondary outcomes
Symptom Checklist-90-Revised (SCL-90-R®)
Time frame: Before and 6 months after therapy
Preferred Chewing Side
Time frame: Before and 6 months after therapy
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
Condylar Path Angles
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José López-Cedrún Cembranos, MD, DDS, PhD principal investigator
Complejo Hospitalario Universitario de La Coruña
Urbano Santana Penín, MD, DDS, PhD study director
Universidad de Santiago de Compostela
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Occlusal adjustment in people with Temporomandibular Joint Disorders and Orofacial Pain, run by University of Santiago de Compostela at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogic Scale for Pain Intensity (0-10) (time frame: Baseline, immediately after therapy, 3 months and 6 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.