ISRCTN61654487已完成未知
Restoring physiological jaw closure and MAsticatory function as treatment for chronic Pain: a randomized clinical trial
niversity of Santiago de Compostela (Universidad de Santiago de Compostela) (Spain)0 个研究点目标入组 21 人开始时间: 2014年7月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23593156
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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)
研究者
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