The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies: a Randomized Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
研究概览
简要总结
In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.
Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.
The endpoints will be :
Primary endpoint:
• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.
Secondary endpoints:
- Change in pain intensity measured by visual analog scale (VAS).
- Improvement of functional indicators of the temporomandibular joint, including range of motion.
- Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.
- •Presence of diseases of the musculoskeletal system, confirmed orthopedist or rheumatologist.
- •Acquired limb deformities (for example, flat feet, valgus or varus deformity).
- •Deforming dorsopathies (kyphosis, lordosis, scoliosis, osteochondrosis).
- •Consent to participate in the study and follow the treatment protocol.
- •Sufficient general physical and mental fitness to participate in the study
排除标准
- •Systemic diseases affecting bone metabolism (eg osteoporosis).
- •Progressive neurological diseases.
- •Current treatment with steroids or immunosuppressive drugs.
- •Presence of malignant neoplasms.
- •Psychiatric disorders that prevent compliance protocol.
- •Pregnancy or lactation period.
- •Carrying out dental or orthopedic treatment in recent 6 months.
- •Skeletal malocclusions.
- •Diseases of the temporomandibular joint.
- •Congenital pathologies of the musculoskeletal system.
- •Arthropathy.
- •Systemic connective tissue diseases.
- •Biomechanical lesions of the musculoskeletal system.
研究组 & 干预措施
receive standard treatment group
干预措施: at correcting malocclusions or restoring the integrity of the dentition (Procedure)
comprehensive treatment group
干预措施: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system. (Procedure)
结局指标
主要结局
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
时间窗: 12 months
次要结局
- Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.(12 month)
- Change in pain intensity measured by visual analog scale (VAS).(12 months)
- Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale(12 month)