Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Pain in the Temporomandibular Joint and/or masticatory muscles
研究概览
简要总结
The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of legal age
- •Both sexes
- •Regardless of race or social class
- •With the main complaint of pain in the temporomandibular joint or orofacial region
- •With or without limitation of mouth opening, diagnosed through the DC/TMD axis1, with pain in the masticatory mm and muscular TMD
- •Participants must have complete permanent dentition and normal occlusion.
排除标准
- •Congenital problems affecting the TMJ and/or orofacial and cervical region of the skull;
- •Neoplastic conditions;
- •History of recent trauma to the orofacial/cervical region of the skull;
- •Previous use of any type of TMD treatment plate;
- •Current use of functional orthopedic appliances or fixed and/or removable orthodontic appliances;
- •Cleft lip and/or palate syndromes;
- •Psychiatric disorders;
- •Severe cardiac problems;
- •A severely poor dental condition such as periodontitis and/or indication for endodontic treatment;
- •Those using topical or systemic photosensitizing drugs;
- •Pregnant women;
- •Dermatological diseases in the region where irradiation will be performed;
- •Patients with impaired cognitive ability;
- •History of head trauma related to the etiology of orofacial pain;
- •Migraine or intracranial disorders;
- •Who used medications in the last 3 months that may interfere with the effect of therapies, such as relaxants, anticonvulsants and who used medications to treat TMD or muscular pain;
- •Who had other causes of orofacial pain, such as caries, neuropathies and fibromyalgia;
- •Who had phobia about needles or bleeding disorders;
- •Patients who are unable to attend the clinic during the prescribed treatment period;
- •Patient who insists on a specific treatment (e.g. occlusal adjustments, medication);
- •Presence of removable full or partial dentures with distal extension.
研究组 & 干预措施
Occlusal Splint + Acupuncture Laser Therapy
In the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period.
干预措施: Occlusal Splint (Device)
Occlusal Splint
Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical.
After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.
干预措施: Occlusal Splint (Device)
Laser Therapy
All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not.
The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.
干预措施: Laser Therapy (Radiation)
Occlusal Splint + Laser Therapy
The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.
干预措施: Occlusal Splint (Device)
Occlusal Splint + Laser Therapy
The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.
干预措施: Laser Therapy (Radiation)
Acupuncture Laser Therapy
The laser will be applied to predetermined acupuncture points and specific trigger points identified during the clinical examination. The application will be performed symmetrically and bilaterally, regardless of the presence of trigger points. A standardized protocol will be followed for all participants, irrespective of tissue thickness or gender. The equipment to be used will emit an infrared light beam with a wavelength of 808 nm, output power of 100 mW, energy density of 105 J/cm², and a spot size of 0.028 cm², delivering 3 J per point, which corresponds to a 30-second application per point. The protocol will consist of five applications: one at baseline, followed by four weekly sessions.
干预措施: Acupuncture Laser Therapy (Radiation)
Occlusal Splint + Acupuncture Laser Therapy
In the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period.
干预措施: Acupuncture Laser Therapy (Radiation)
结局指标
主要结局
Pain in the Temporomandibular Joint and/or masticatory muscles
时间窗: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.
The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain.
次要结局
- Mouth opening(Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.)
- Oral Health Impact Profile(Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.)
研究者
Daniel Augusto de Faria Almeida
Principal Investigator
Universidade Federal de Alfenas