Improving chewing function to treat chronic pai
- Conditions
- Facial pain: Chronic temporomandibular joint (TMJ) disorders (TMD)Digestive SystemTemporomandibular joint disorders
- Registration Number
- ISRCTN61654487
- Lead Sponsor
- niversity of Santiago de Compostela (Universidad de Santiago de Compostela) (Spain)
- Brief Summary
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23593156
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Current inclusion criteria as of 04/05/2016:
1. Pre-screened patients satisfying the TMD-pain instrument (Gonzalez et al., 2011); TMD-pain diagnosis requires each of two findings: pain of sufficient frequency across a recent period and modification of the pain by jaw function. Assessors (JLC, FLF, MPC) will apply this instrument for eligibility
2. Patients suffering self-reported significant chronic TMD-pain (Joint and/or Muscle pain) according to DC/TMD (Schiffman et al., 2014)
3. Aged 18–65 years
4. Completely dentate adults with normal (or adequately restored with fixed crowns or bridges) occlusion
5. Suffering from significant TMD-pain (=4 and =9 scores, in a 0–10 visual and/or numerical analogue scale-VAS/NRS; 0 = no pain to 10 = worst possible pain)
6. Had requested therapy for TMD-pain, referred to the Hospital/University Service
7. After more than 6 months of treatment with conservative therapies
Previous inclusion criteria:
TMD patients, aged 18-65 years with full dentates and normo-occlusion suffering significant pain (pain scores =4 and =9; method: visual analogue scale (VAS); 0 = no pain, 10 = worst imaginable pain)
Current exclusion criteria as of 04/05/2016:
1. Psychosis
2. Major depression
3. Substance abuse
4. Cognitive impairment
5. Addiction to morphine or derivatives
6. Litigation or asking for disability/retirement compensation for chronic pain
7. Dental care professionals
8. Orthodontic therapy during the last 2 years
9. Degree 2 to 3 of tooth mobility
10. Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain
11. Individuals for whom minimally-invasive occlusal adjustment could not achieve occlusal equilibration (assessed by the experts in occlusion, Drs. USM, MJM), to minimize tissue removal. Over 2 mm of difference between the maximal intercuspal position and the centric occlusion; and/or over 4 mm (2 mm on any side) of difference between upper and lower arches measured: between the mesial fossae of the first upper premolars with respect to the cusps of the first lower premolars; and the mesiopalatal cusp of the first upper molars with respect to the central fossae of the first lower molars. A Boley gauge (Beerendonk, nº REF 042-750-00; Dentaurum GmbH & Co., KG, Ispringen, Germany) will be used for these intraoral measurements
12. No periodontal disease (except for chronic severe cases with grade 2–3 mobility), fibromyalgia nor neuropathic pains are exclusion criteria
Previous exclusion criteria:
Main exclusion criterion is the requirement of excessive enamel removal to equilibrate the dental articulation (occlusion)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 04/05/2016:<br> Self-reported affected-side pain-intensity across the trial (baseline, 3- and 6-Months) on a 0–10 numerical rating (NRS) or visual analogue (VAS) scales (0 = no pain, 10 = worst possible pain). One after-MAP time: 9-12-Months after therapy is anticipated. Independent assessment. According to Comet Initiative, this outcome assessment follows the IMMPACT guidelines (DOI: 10.1016/j.pain.2004.09.012).<br><br> Previous primary outcome measures:<br> Self-reported pain intensity on the affected side. Measurement method: visual analogue scale (VAS); 0 = no pain, 10 = worst imaginable pain. Time points: baseline, 3 months and 6 months follow-up.<br>
- Secondary Outcome Measures
Name Time Method