ClinicalTrials.gov
ClinicalTrials.gov Menu

Restoring Masticatory Function to Treat Chronic Pain (MAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02144233
Recruitment Status : Terminated (Interim analysis showed benefice of one therapy over the other one.)
First Posted : May 21, 2014
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
University of Santiago de Compostela
Information provided by (Responsible Party):
Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela

Brief 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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Dysfunction Syndrome Chronic Pain Procedure: Occlusal adjustment Procedure: Placebo occlusal adjustment Not Applicable

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 CHUAC 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.

Aditional patient's monitoring until next five years after treatment is expected.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Occlusal adjustmen therapy
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 LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness.
Procedure: Occlusal adjustment

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)

Other Names:
  • Occlusal reshaping
  • Selective grinding of teeth
  • Restoring physiological jaw-closure
  • Restoring impaired chewing function

Placebo Comparator: Placebo occlusal adjustment therapy
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.
Procedure: Placebo occlusal adjustment
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.




Primary Outcome Measures :
  1. Jaw-pain-Intensity (affected side) [ Time Frame: Baseline, after therapy, 3-Months, 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.


Secondary Outcome Measures :
  1. Chewing function (alternate vs. one habitual chewing side) [ Time Frame: baseline, 3- and 6-Months ]
    1. Clinically observed habitual chewing side: a) if at less 7/10 almonds by the same side; alternately the side used at 15, 20 or 25 s during chewing gum (Christensen and Radue, 1985) b) the side used first during kinesiographic recordings.
    2. Interview: actual and retrospective subjective chewing function. (Alternate, right, left, I dont know). The change from the habitual chewing side to the oposite side or alternate represent a better outcome.

  2. Quality of life. SCL-90-R scores [ Time Frame: Baseline, 6-Months ]
    Self-administered Spanish validated questionaire SCL-90-R (Derogatis et al., 1976; González de Rivera et al., 1989). Higher values represent a worse outcome.

  3. Maximum unassisted jaw opening [ Time Frame: Baseline, inmediate after therapy, 3- and 6-Months ]
    Vertical jaw-opening (incisal level) measured by a Boley gauge. Higher values represent a better outcome.


Other Outcome Measures:
  1. Maximum lateral jaw-displacement (incisal level) [ Time Frame: Baseline, end of the sutdy (6-Months) ]
    Assessed by Kinesiography

  2. Percent of time suffering significant pain (0% to 100%) [ Time Frame: Baseline, 3-Mo, 6-Mo ]
    Numerical rating Scale: from 0%=never to 100%=always with severe pain.

  3. Pain-Intensity on the initially unaffected side [ Time Frame: Baseline, 3-Mo, 6-Mo ]
    Self-reported unaffected side pain-intensity across the trial in a 0-10 visual analogue scale (0=no pain, 10=worst possible pain)

  4. Pain-dimensions [ Time Frame: Baseline, 6-Months ]
    McGill Pain questionnaire

  5. Neuropathic pain [ Time Frame: Baseline, 6-Months ]
    DN4 Questionnaire

  6. TMD-related impairment [ Time Frame: Baseline, 6-Mo ]
    MFIQ (Stegenga et al, 1993)

  7. Circulating biomarkers [ Time Frame: Baseline, 6-Months ]
    Blood levels

  8. Periodontal disease (if indicated) [ Time Frame: Baseline, 6-Months ]
    Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility

  9. Handedness preference [ Time Frame: Baseline ]
    Edinburgh Inventory

  10. Hemimandibular retrognathia [ Time Frame: Baseline ]
    Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position

  11. Lateral Guidance angles [ Time Frame: Baseline, postherapy, 6-Mo ]
    The angle between the tangent of the lateral anterior guidance tracings and the horizontal (bimeatus) Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system (Myotronics-Noromed, Inc., Kent, WA, US)

  12. Condylar Path Angles [ Time Frame: Baseline, 6-Months ]
    Condylar path tracings in relation to the Frankfort line in the parasagittal plane by following the Gysi extraoral method

  13. Credibility (of participants) [ Time Frame: Baseline, 6-Months ]
    Credibility test of Borkovec and Nau (1972)

  14. Blinding of patients and researchers (except the caregiver) [ Time Frame: After therapy and at the end of the study ]
    Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved

  15. Adverse Events [ Time Frame: After therapy, 1-Month, 3-Months, 6-Months ]
    Unexpected Adverse Events (NIH, 2009).

  16. Occlusal forces/pressure [ Time Frame: Baseline; 6-Months ]
    Dental prescale fuji-film

  17. Pain interference on daily activity [ Time Frame: Baseline; 6-Months ]
    0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities)

  18. Patient impression (Improvement) [ Time Frame: 6-Months ]
    Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse

  19. Full, assisted mouth opening [ Time Frame: Baseline, after-therapy, 3-Months, 6-Months ]
    Interincisal distance during jaw-opening. Meassurenet method: Boley gauge.

  20. Patient's perception of reduced movement [ Time Frame: Baseline, 6-Months ]
    Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.

  21. Protrusive motion [ Time Frame: Baseline, 6-Months ]
    Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome.

  22. Sociodemography [ Time Frame: Baseline, 6-Months ]
    Social condition (Elliott et al., 2005)

  23. Maximum comfortable (without pain) jaw opening [ Time Frame: Baseline, inmediate after therapy, 3- and 6-Months ]
    Vertical jaw-opening (incisal level) measured by a Boley gauge.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 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 (0 - 10 VAS scale)
  • Chronic (over 6 months) joint and/or muscle pain, according to DC/TMD, for which they had requested therapy

Exclusion Criteria:

  • Psychosis
  • Major depression
  • Substance abuse
  • Cognitive impairment
  • Addiction to morphine or derivates
  • Litigation or asking for disability/retirement compensation for chronic pain
  • 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 fosaes 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

Information from the National Library of Medicine

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): NCT02144233


Locations
Spain
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, Galicia, Spain, 15782
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña. Galicia, Spain, 15006
Sponsors and Collaborators
Urbano Santana Penin, MD, DDS, PhD
University of Santiago de Compostela
Investigators
Principal Investigator: Urbano Santana-Penin, Prof University of Santiago de Compostela
Study Chair: Jose Lopez-Cedrun, Dr University Hospital Complex of La Coruña
Study Director: Maria J Mora, Prof University of Santiago de Compostela
Principal Investigator: Urbano Santana-Mora, Dr University of Santiago de Compostela

Publications:
Responsible Party: Urbano Santana Penin, MD, DDS, PhD, Prof., University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT02144233     History of Changes
Other Study ID Numbers: U1111-1134-0832
PI11/02507 ( Other Grant/Funding Number: Ministry of Science and Innovation (Spain) )
ISRCTN ( Registry Identifier: 61654487 )
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 FigShare venue. The protocol will be attached as a supplementary appendix to the main manuscript

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The raw data of each participant, unidentifiable, will be accessible within 6 months after the publication of the manuscript and will be accessible for at least one year.
Access Criteria: Free access

Keywords provided by Urbano Santana Penin, MD, DDS, PhD, University of Santiago de Compostela:
Pain
Temporomandibular joint disorders
Occlusal adjustment
Therapy
Randomized clinical trial
Mastication
Habitual chewing side
Handedness preference
Hemimandibular retrognathia

Additional relevant MeSH terms:
Chronic Pain
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents