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Restoring Masticatory Function to Treat Chronic Pain (MAP)

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome, Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Occlusal adjustment
Placebo occlusal adjustment
Sponsored by
Urbano Santana Penin, MD, DDS, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring Pain, Temporomandibular joint disorders, Occlusal adjustment, Therapy, Randomized clinical trial, Mastication, Habitual chewing side, Handedness preference, Jaw asymmetry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

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 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

Sites / Locations

  • Universidad de Santiago de Compostela
  • Complexo Hospitalario Universitario A Coruña

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Occlusal adjustment therapy

Placebo occlusal adjustment therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Maximum Unassisted Jaw Opening
Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.

Full Information

First Posted
May 19, 2014
Last Updated
April 11, 2020
Sponsor
Urbano Santana Penin, MD, DDS, PhD
Collaborators
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT02144233
Brief Title
Restoring Masticatory Function to Treat Chronic Pain
Acronym
MAP
Official Title
Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed benefice of one therapy over the other one.
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Urbano Santana Penin, MD, DDS, PhD
Collaborators
University of Santiago de Compostela

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome, Chronic Pain
Keywords
Pain, Temporomandibular joint disorders, Occlusal adjustment, Therapy, Randomized clinical trial, Mastication, Habitual chewing side, Handedness preference, Jaw asymmetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occlusal adjustment therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo occlusal adjustment therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Occlusal adjustment
Other Intervention Name(s)
Occlusal reshaping, Selective grinding of teeth, Restoring physiological jaw-closure, Restoring impaired chewing function
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Placebo occlusal adjustment
Intervention Description
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 Measure Information:
Title
Jaw-pain-Intensity (Affected Side)
Description
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.
Time Frame
Baseline and 6-months
Secondary Outcome Measure Information:
Title
Chewing Side
Description
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.
Time Frame
Baseline and 6-months
Title
Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))
Description
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).
Time Frame
Baseline, 6-Months
Title
Maximum Unassisted Jaw Opening
Description
Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.
Time Frame
Baseline, 3- and 6-Months
Other Pre-specified Outcome Measures:
Title
Headache-intensity
Description
Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.
Time Frame
Baseline 3- and 6-Months
Title
Number of Participants With Neuropathic Pain
Description
Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.
Time Frame
Baseline, 6-Months
Title
Handedness Preference
Description
Handedness preference assessed using Edinburg inventory: Left Right Writing Drawing Throwing Scissors Toothbrush Knife (without fork) Spoon Broom (upper hand) Striking Match (match) Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?
Time Frame
Baseline
Title
Lateral Guidance Angles (LG)
Description
The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.
Time Frame
Baseline
Title
Condylar Path Angles
Description
Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.
Time Frame
Baseline
Title
Adverse Events
Description
Unexpected Adverse Events (NIH, 2009).
Time Frame
After therapy, 1-Month, 3-Months, 6-Months
Title
Jaw Asymmetry
Description
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
Time Frame
Baseline
Title
Participant's Awareness With Trial Group Assignment
Description
Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved
Time Frame
Six months
Title
Credibility (of Participants)
Description
Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally.
Time Frame
Baseline, 6-Months
Title
Sociodemography
Description
Level of education
Time Frame
Baseline
Title
Patient Impression (Improvement)
Description
Patient impression outcome will be reported as Improved Vs. no change.
Time Frame
6-Months
Title
Pain Interference on Daily Activity
Description
In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify.
Time Frame
Baseline; 6-Months
Title
Pain-dimensions
Description
McGill Pain questionnaire
Time Frame
Baseline, 6-Months
Title
Temporomandibular Disorders Related Impairment
Description
Mandibular Function Impairment Questionnaire (MFIQ)
Time Frame
Baseline, 6-Mo
Title
Circulating Biomarkers
Description
Blood levels of Circulating Biomarkers
Time Frame
Baseline, 6-Months
Title
Periodontal Disease (if Indicated)
Description
Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility
Time Frame
Baseline, 6-Months
Title
Occlusal Forces/Pressure
Description
Dental or occlusal forces measured using fuji-film method.
Time Frame
Baseline; 6-Months
Title
Maximum Comfortable (Without Pain) Jaw Opening
Description
Vertical jaw-opening (incisal level) measured using a ruler.
Time Frame
Baseline, immediate after therapy, 3- and 6-Months
Title
Patient's Perception of Reduced Movement
Description
Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.
Time Frame
Baseline, 6-Months
Title
Protrusive Motion
Description
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.
Time Frame
Baseline, 6-Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urbano Santana-Penin, Prof
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Lopez-Cedrun, Dr
Organizational Affiliation
University Hospital Complex of La Coruña
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria J Mora, Prof
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Urbano Santana-Mora, Dr
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña, Galicia
ZIP/Postal Code
15782
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
A Coruña. Galicia
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 a repository. The protocol will be attached as a supplementary appendix to the main manuscript
IPD Sharing 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.
IPD Sharing Access Criteria
Free access
Citations:
PubMed Identifier
23593156
Citation
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.
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Restoring Masticatory Function to Treat Chronic Pain

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