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临床试验/NCT05422703
NCT05422703已完成不适用

Combined Effect of Manual Therapy and Kinesio Taping on Temporomandibular Joint Dysfunction Following Oral Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Facial pain

研究概览

简要总结

Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abcess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF). Oral surgeries are usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth days postoperatively for the swelling and 24 to 48 hours postoperatively for the pain and then, they gradually diminished until the 7th day postoperatively

详细描述

Oral surgery concerned with the diagnosis and surgical treatment of congenital or acquired diseases, dysfunction, defects or injuries of the mouth and jaw. Oral surgeries include various types such as impacted wisdom tooth surgery, oral cyst enucleation (cystectomy), surgical incision and drainage of odontogenic abscess, oral tumor excision and open reduction and internal fixation of mandibular fracture (ORIF).

Temporomandibular joint dysfunction: It is one of post operative complications that occur post oral surgeries which include several symptoms as pain,edema and trismus. Pain is the most common and limiting clinical manifestation of this dysfunction, as well as decreased mobility of the jaw, both of which impacts quality of life. The multifactor etiology of temporomandibular joint dysfunction often requires multidisciplinary healthcare professionals to manage difficult symptoms, including chronic pain. Many studies have identified a variety of conservative interventions, such as physical therapy, for patients with temporomandibular joint disorders, including joint mobilization, tissue mobilization,dry needling, friction massage, patient education, splints, modalities, stretching, coordination activities,strengthening exercises, and combinations of these techniques. postoperative major complications such as pain, edema and trismus in various oral surgeries such as tooth extraction, maxillary expansion, and orthognathic surgeries. Oral surgical procedures are often accompanied by a multitude of complications including pain, swelling, and morbidity. These are the result of inflammatory processes induced by the surgical wound healing.

Facial edema: During surgeries, inflammatory chemicals such as prostaglandins, leukotrienes, bradykinins, and platelet-activation factors are secreted by damaged tissue. Moreover, excessive lymph production causes disturbances in local lymphatic circulation. Inflammatory chemicals create endothelial gaps to increase vascular permeability. In addition, macrophages and mast cells in damaged tissues produce histamine, serotonin, and eicosanoids; alter the local constitution of blood vessels; and release nitric oxide, eventually resulting in vasorelaxation. These chain reactions increase blood vessel relaxation and vascular permeability and result in the accumulation of interstitial fluid, eventually resulting in tissue swelling and pain.

Trismus: It is defined as prolonged tetanic spasm of masticatory muscles of jaw. the transient jaw stiffness usually reaches its peak on the 2nd day post surgery. It is diagnosed from clinical examination of the maximal interincisal distance (MID) <40-45 mm caused by contracture and not by obstructive joint impingement.The factors contributing to trismus are: (1) Multiple needle penetrations correlate with a greater incidence of post injection trismus. (2) Elevation of flap beyond the external oblique ridge. (3) At times, the patient hurts his/her own tongue or cheek under the effect of anesthesia resulting in reflex trismus.

kinesio taping (KT) was developed by the Japanese therapist and academic lecturer. More than 30 years ago, he created a special tape, which by the correct application, i.e. sticking with a small stretch (about 15%) to the skin, raises the surface of the skin, thereby increasing the space between the dermis and fascia . The expansion of this space, should reduce lymph retention. The patch used for this method has a thickness and weight similar to skin. The waterproof tape is made of 100% cotton, while the adhesive on the inside is applied in the shape of a fan strip, which allows the air to flow. When stretched beyond its normal length and applied, it recoils and creates a pulling force on the skin, thus improving blood and lymph flow by alleviating hemorrhage and congestion of lymphatic fluid.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age ranged between 20-50 years
  • both gender
  • TMJ dysfunction following oral surgeries.

排除标准

  • open wound in affected area
  • facial trauma,smoker and infection
  • sensitivity to tape
  • allergies to medication administered in the study
  • reluctance to shave facial hair (for men)

研究组 & 干预措施

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Kinesio tape (Device)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Gauze pack (Other)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: ice pack (Device)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Manual therapy (Procedure)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Analgesic (Drug)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Proteolytic enzymes (Drug)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Mouth wash (Drug)

Study group

Experimental

patients who will receive manual therapy and Kinesio taping, in additional to basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ) 3 times per week for two weeks.

干预措施: Soft cold diet (Dietary Supplement)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: Gauze pack (Other)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: ice pack (Device)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: Analgesic (Drug)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: Proteolytic enzymes (Drug)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: Mouth wash (Drug)

Control group

Placebo Comparator

patients who will receive basic post operative care (ice pack , analgesics, Antibiotic treatment and mouth wash daily ).

干预措施: Soft cold diet (Dietary Supplement)

结局指标

主要结局

Facial pain

时间窗: Two weeks

Visual analogue scale (VAS)measure, consists of a line usually 10 cm in length, with anchor descriptors such as (in the pain context) where 0 means no pain and 10 means worst conceivable pain. patients asked to mark the point corresponding to the intensity of their pain , and the distance from the left endpoint to the mark is measured, in cm.

Maximum mouth opening

时间窗: Two weeks

measurement of maximal interincisal distance (mm) attained during the active mouth opening by the subject.

facial swelling

时间窗: Two weeks

Facial swelling was assessed by a four-line measurement method using a flexible plastic tape measure. The corresponding lines were line A from the most posterior point of the tragus to the most lateral point of the lip commissure),line B (from the most posterior point of the tragus to the pogonion), line C from the most inferior point of the mandibular angle to lateral canthus of the eye ; and line D, most inferior point of the mandibular angle to (the nasal border - wing of the nostril. These measurements were performed with the patient sitting at 90° straight position with physiologic rest position of the mandible.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Kamal Mousa Mohamed

Combined effect of manual therapy and kinesiotaping on temporomandibular joint dysfunction following oral surgeries

Cairo University

研究点 (1)

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