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临床试验/CTRI/2024/02/062579
CTRI/2024/02/062579招募中2 期

Evaluation of ozone therapy in comparison with occlusal splint in treating internal derangement of temporomandibular joint : a randomized controlled study

Satyendra Pratap Singh1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
28
试验地点
1
主要终点
To compare the effects of occlusal splint therapy and ozone therapy in terms of pain, mouth opening, lateral Mandibular excursion in temporomandibular joint disorders with internal disc derangement

研究概览

简要总结

The synovial articulation between the mandible and temporal bone is known as the temporomandibular joint (TMJ). Only mammals have this joint. The condylar head of the mandible, the temporal bone’s articulating surfaces, the articulating disc, and the articulating capsule make up this joint. The disc divides the TMJ cavity into upper and lower compartments and detaches the head of the condyle from the temporal bone. It offers a passively movable articular surface that allows the condylar head’s translatory movement.

Disorders of the temporomandibular joint are quite prevalent, with a prevalence of about 52%. It is a broad word that really refers to a variety of clinical conditions that affect the TMJ and other structures connected to the masticatory system. They have a range of etiologies, including congenital, inflammatory, and traumatic. Moreover they exhibit poor wound healing and fibrosis brought on by ongoing, irreparable damage.

TMJ problems impact the jaw joints and associated tissues, resulting in internal joint space derangement bone changes, and degenerative diseases. Disc displacements, with or without decrease, are among the internal TMJ disorders that frequently cause joint noises, pain, and discomfort in the TMJ region the current goals of treating temporomandibular joint diseases include reducing pain while doing daily activities and restoring a normal range of mandibular movements. Many therapeutic approaches are recommended for re-establishing the balance of the TMJ system, including conservative treatments including diet control, antidepressant medications/non- steroidal anti-inflammatory drugs (Nsaids), physiotherapy, and splints. Also taken into consideration are surgical procedures including arthrocentesis, arthroscopy, and open joint surgeries.

The method of ozone and splint avoids the use of surgery as the first line of treatment and also overcomes the complications associated with direct intra articular injections of autologous blood and sclerosing agents. Ozone not only give symptomatic treatment, but it also helps in regeneration of the joint. Splints are frequently used in patients with TMD to reduce abnormal muscle activity, increase vertical height, and improve the stability of the TMJ.

Now a days thermal imaging technology is being used for detection of temperature of joint. Increase or decrease in temperature has a direct relation with aggravation or reduction of inflammation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy subjects with moderately severe and chronic pain and jaw dysfunction with compromised mouth opening.

排除标准

  • Dental problem or sinus pathology potentially contributing to pain, b.
  • Immunocompromised patients.
  • Psychologically compromised patients.
  • Allergy to Local anesthesia e.
  • Active rheumatological condition.
  • Pain due to infection g.
  • G6PD Deficiency h.
  • Pregnancy or breast feeding.
  • Osseous defects j.
  • TMJ disarticulation.
  • Myofascial pain dysfunction as the sole or primary source of pain.
  • Edentulous subjects.
  • Limited opening secondary to extra-articular pathology.
  • Fibromyalagia.
  • Allergy to study medication.

结局指标

主要结局

To compare the effects of occlusal splint therapy and ozone therapy in terms of pain, mouth opening, lateral Mandibular excursion in temporomandibular joint disorders with internal disc derangement

时间窗: 1 week , 1 month , 3 month , 6 month

次要结局

  • To compare the effects of occlusal splint therapy and ozone therapy in terms of inflammation using thermoscan (FLIR make Thermal Imaging Camera – C5).(1 week , 1 month , 3 month , 6 month)

研究者

发起方
Satyendra Pratap Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Satyendra Pratap Singh

Faculty of dental sciences, Kgmu , Lucknow

研究点 (1)

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