Restoring Masticatory Function to Treat Chronic Pain
TerminatedNot applicableNCT02144233
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Restoring Masticatory Function as Treatment for Chronic Pain: a Randomized Placebo-controlled Trial
- Conditions
- Temporomandibular Joint Dysfunction Syndrome
- Chronic Pain
- Interventions
- Procedure: Occlusal adjustment
- Procedure: Placebo occlusal adjustment
- Sponsor
- Urbano Santana Penin, MD, DDS, PhD
- Collaborators
- University of Santiago de Compostela
- Organization
- University of Santiago de Compostela
- Start date
- 2014-08
- Primary completion
- 2018-06-15
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Spain
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02144233