Clinical Trial: Restoring Masticatory Function to Treat Chronic Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial

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 Summary:

• 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 stop
  Sponsor: Urbano Santana Penin, MD, DDS, PhD
  

  Current Primary Outcome: 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 (VAS) and/or numerical rating (NRS) scale (0=no pain, 10=worst possible pain)
  
  
  

  Original Primary Outcome: Pain-Intensity (affected side) [ Time Frame: up to 6-Months ]

  Self-reported spontaneous affected-side pain-intensity across the trial in a 0-10 visual analogue scale (0=no pain, 10=worst possible pain)
  
  
  

  Current Secondary Outcome:

  • 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)
  • Quality of life [ Time Frame: Baseline, 6-Months ]
    Self-administered Spanish validated questionaire SCL-90-R (Derogatis et al., 1976; González de Rivera et al., 1989)
  • Maximum unassisted jaw opening [ Time Frame: Baseline, inmediate after therapy, 3- and 6-Months ]
    Vertical jaw-opening (incisal level) measured by a Boley gauge.
  
  
  

  Original Secondary Outcome:

  • Maximum unassisted jaw opening [ Time Frame: Baseline, inmediate after therapy, 3- and 6-Months ]
    Vertical jaw-opening (incisal level) measured by a Boley gauge.
  • 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 gnatographic recordings during.
    2. Interview: actual and retrospective subjective chewing function. (Alternate, right, left, I dont know)
  • Quality of life [ Time Frame: Baseline, 6-Months ]
    Assessed by the self-administered Spanish validated questionaire SCL-90-R (Derogatis et al., 1976; González de Rivera et al., 1989)
  
  
  Information By: University of Santiago de Compostela
  

  Dates:
  Date Received: May 19, 2014
  Date Started: August 2014
  Date Completion: November 2018
  Last Updated: February 2, 2017
  Last Verified: February 2017