Restoring Masticatory Function to Treat Chronic Pain (NCT02144233) | Clinical Trial Compass
TerminatedNot Applicable
Restoring Masticatory Function to Treat Chronic Pain
Stopped: Interim analysis showed benefice of one therapy over the other one.
Spain77 participantsStarted 2014-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 low…