Temporomandibular Joint Dysfunction SyndromeMAPNCT02144233
Restoring Masticatory Function to Treat Chronic Pain
A study testing Occlusal adjustment in people with Temporomandibular Joint Dysfunction Syndrome and Chronic Pain, run by Urbano Santana Penin, MD, DDS, PhD at 2 sites in Spain.
Trial summary
The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome, Chronic 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
- 77 participants
- Where
- 2 sitesSpain
- Study dates
- Aug 2014to 15 Jun 2018
- Phase
- Interventional
- 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
- Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides)
- Normal Angle Class I occlusion
- Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS).
- Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy
Who cannot join
- Psychosis
- Major depression
- Substance abuse
- Cognitive impairment
- Addiction to morphine or derivates
- Litigation or asking for disability/retirement compensation for chronic pain
Show all 11Show fewer
- Dental care professionals
- Orthodontic therapy during the last 2 years
- Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain
- Individuals for whom minimally invasive occlusal adjustment could not achieve occlusal equilibration, including: Over 2 mm of difference between the maximal intercuspal position and the centric occlusion or over 4 mm of difference between upper and lower archs (or over 2mm on at less one side) measured: between the mesial fosses of first upper premolars with respect the buccal cusps of the first lower premolars; and/or between the mesiopalatal cusp of the first upper molars respect to the central (mesial) fossae of the first lower molar.
- Severe periodontal disease with grade 3 mobility
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña. Galicia, 15006
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, Galicia, 15782
About this study
Official title: Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.
Read the detailed description
- The cause of temporomandibular joint (TMJ) disorders (TMD) remains unknown and therapy is usually empirical. Systematic reviews have concluded that currently there is no evidence that occlusal adjustment has any therapeutic or preventive effect on temporomandibular disorders. However, these reviews also indicate that evidence to the contrary has not been provided and that more research is needed to elucidate whether there is any benefit of occlusal adjustment treatment for TMD. The risk factors for chronic unilateral TMD include a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the affected side. Consequently, a new occlusal therapy is proposed to restore the physiological jaw closure and masticatory function.
- The primary end point of the trial is to assess the efficacy of the new occlusal therapy on the affected side TMD pain, and the maximum mouth opening. Efficacy is demonstrated by showing significantly superior pain relief and increasing maximum mouth opening (when it was limited) with the active treatment compared with placebo.
Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial.
- A linear mixed model will be performed for comparisons of most variables and a logistic regression model will be used to measure the probability/risk of change on the chewing side between baseline and six months; in addition, McNemar's test may be used.
- Interim analysis plan and stopping rules. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146.
Participants remaining with significant pain (and/or limited mouth opening) after the study will be invited to follow the conventional treatment, or to "complete" occlusal adjustment (rescue therapy): the full adjustment (if they were placebos), or a refining (if they received real therapy); the kind of received therapy will not be disclosed to participants. It based on the researchers' conviction, participants are encouraged to receive electively "complete" occlusal adjustment. All participants will be reevaluated between 3 to 6 months after study (12-Mo follow-up). Although no pain was reported at the 6-Mo follow-up, if pain returns, same approach will be carried out. Two sessions occlusal adjustment will be carried out and, if the pain remains, the patient will be treated following the Hospital approaches. The evolution of patients during post-MAP period, until writing of the manuscript, will be reported in the same manuscript, even if MAP result early stopped.
Additional patient's monitoring until next five years after treatment is expected.
- Being tested
- Occlusal adjustment, Placebo occlusal adjustment
- Keywords
- Pain, Temporomandibular joint disorders, Occlusal adjustment, Therapy, Randomized clinical trial, Mastication, Habitual chewing side, Handedness preference, Jaw asymmetry
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Chronic Pain, Pain, Temporomandibular Joint Disorders
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 Occlusal reshaping, Selective grinding of teeth, Restoring physiological jaw-closure, Restoring impaired chewing function
The first step consists of the elimination of premature tooth contacts during retruded jaw closure.
The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)
Placebo occlusal adjustmentProcedure or surgery
Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal adjustment therapy | Experimental | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Receives: Procedure: Occlusal adjustment |
| Placebo occlusal adjustment therapy | Placebo comparator | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Receives: Procedure: Placebo occlusal adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw-pain-Intensity (Affected Side)
Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.
Measured: Baseline and 6-months
Secondary outcomes (3)
Chewing Side
A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.
Measured: Baseline and 6-months
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))
Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).
Measured: Baseline, 6-Months
Maximum Unassisted Jaw Opening
Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.
Measured: Baseline, 3- and 6-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startAug 2014
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Why it stopped: Interim analysis showed benefice of one therapy over the other one.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urbano Santana Penin, MD, DDS, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santiago de Compostela
- Responsible party
- Sponsor-investigator, Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela
- Investigators
- Urbano Santana-Penin, Prof, Principal investigator, University of Santiago de CompostelaJose Lopez-Cedrun, Dr, Study chair, University Hospital Complex of La CoruñaMaria J Mora, Prof, Study director, University of Santiago de CompostelaUrbano Santana-Mora, Dr, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144233
- Sponsor's protocol ID
- U1111-1134-0832
- Other IDs
- PI11/02507, ISRCTN
- Acronym
- MAP
- Status last verified
- Apr 2020
- First submitted
- 19 May 2014
- Last updated
- 22 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A closed, certificate, database called OpenClinica allows access to members of the Data and Safety Monitoring Board. We expect to publish raw data in Sci Data. Figures from participant's mouth could be posted in a repository. The protocol will be attached as a supplementary appendix to the main manuscript
Publications
Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.
PubMed 23593156
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02144233
- Acronym / sponsor ID
- MAP / U1111-1134-0832
- Keywords
- Pain, Temporomandibular joint disorders, Occlusal adjustment, Therapy, Randomized clinical trial, Mastication, Habitual chewing side, Handedness preference
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed benefice of one therapy over the other one.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Urbano Santana Penin, MD, DDS, PhDUniversity, hospital or other
- Collaborators
- University of Santiago de Compostela
- Study start
- Aug 2014 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 22 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.
Detailed description
- The cause of temporomandibular joint (TMJ) disorders (TMD) remains unknown and therapy is usually empirical. Systematic reviews have concluded that currently there is no evidence that occlusal adjustment has any therapeutic or preventive effect on temporomandibular disorders. However, these reviews also indicate that evidence to the contrary has not been provided and that more research is needed to elucidate whether there is any benefit of occlusal adjustment treatment for TMD. The risk factors for chronic unilateral TMD include a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the affected side. Consequently, a new occlusal therapy is proposed to restore the physiological jaw closure and masticatory function.
- The primary end point of the trial is to assess the efficacy of the new occlusal therapy on the affected side TMD pain, and the maximum mouth opening. Efficacy is demonstrated by showing significantly superior pain relief and increasing maximum mouth opening (when it was limited) with the active treatment compared with placebo.
Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial.
- A linear mixed model will be performed for comparisons of most variables and a logistic regression model will be used to measure the probability/risk of change on the chewing side between baseline and six months; in addition, McNemar's test may be used.
- Interim analysis plan and stopping rules. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146.
Participants remaining with significant pain (and/or limited mouth opening) after the study will be invited to follow the conventional treatment, or to "complete" occlusal adjustment (rescue therapy): the full adjustment (if they were placebos), or a refining (if they received real therapy); the kind of received therapy will not be disclosed to participants. It based on the researchers' conviction, participants are encouraged to receive electively "complete" occlusal adjustment. All participants will be reevaluated between 3 to 6 months after study (12-Mo follow-up). Although no pain was reported at the 6-Mo follow-up, if pain returns, same approach will be carried out. Two sessions occlusal adjustment will be carried out and, if the pain remains, the patient will be treated following the Hospital approaches. The evolution of patients during post-MAP period, until writing of the manuscript, will be reported in the same manuscript, even if MAP result early stopped.
Additional patient's monitoring until next five years after treatment is expected.
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 |
|---|---|---|
| Occlusal adjustment therapy | Experimental | Procedure: Occlusal adjustmentOcclusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. |
| Placebo occlusal adjustment therapy | Placebo comparator | Procedure: Placebo occlusal adjustmentPlacebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides)
- Normal Angle Class I occlusion
- Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS).
- Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy
Key exclusion criteria (11 listed)
- Psychosis
- Major depression
- Substance abuse
- Cognitive impairment
- Addiction to morphine or derivates
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: Occlusal reshaping, Selective grinding of teeth, Restoring physiological jaw-closure, Restoring impaired chewing functionThe first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) | Procedure or surgery | Occlusal adjustment therapy |
| Placebo occlusal adjustmentPlacebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. | Procedure or surgery | Placebo occlusal adjustment therapy |
Primary outcome
Jaw-pain-Intensity (Affected Side)
Time frame: Baseline and 6-months
Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.
3 secondary outcomes
Chewing Side
Time frame: Baseline and 6-months
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))
Time frame: Baseline, 6-Months
Maximum Unassisted Jaw Opening
Time frame: Baseline, 3- and 6-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23593156Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013.
- Individual participant dataSharing planned: Yes. A closed, certificate, database called OpenClinica allows access to members of the Data and Safety Monitoring Board. We expect to publish raw data in Sci Data. Figures from participant's mouth could be posted in a repository. The protocol will be attached as a supplementary appendix to the main manuscript
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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.
Urbano Santana-Penin, Prof principal investigator
University of Santiago de Compostela
Jose Lopez-Cedrun, Dr study chair
University Hospital Complex of La Coruña
Maria J Mora, Prof study director
University of 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 study testing Occlusal adjustment in people with Temporomandibular Joint Dysfunction Syndrome and Chronic Pain, run by Urbano Santana Penin, MD, DDS, PhD 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Apr 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2020). 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?
Jaw-pain-Intensity (Affected Side) (time frame: Baseline and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144233, which also lists 1 linked publication.
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 22 Apr 2020.