Lymphatic Drainage Massage and Melatonin in Post-Orthognathic Surgery Pain and Edema

Официальное название

The Effect of Lymphatic Drainage Massage and Melatonin on Pain and Edema After Orthognathic Surgery.

Обзор

Lymphatic drainage massage is one of the most essential techniques for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin's surface. This technique accelerates the flow of lymphatic fluid, minimizing swelling and providing relief. Frequently used after orthognathic surgery, lymphatic drainage massage helps reduce edema, enhancing patients' postoperative comfort.

Подробное описание

Melatonin, a hormone produced by the pineal gland, is a neurochemical substance that functions in harmony with the body's natural rhythm. In addition to its presence in the brain, melatonin can also be found in the retina, bone marrow, intestines, skin, and various blood cells. Conditions such as insomnia or jet lag may benefit from melatonin supplements. Beyond its role in improving sleep quality, melatonin also contributes to regulating the immune system, body temperature, blood pressure, and cortisol hormone levels.

Another important function of melatonin is its powerful free radical-scavenging ability. It can neutralize both reactive oxygen species and reactive nitrogen species. Due to its strong antioxidant properties, several studies have investigated its effects on pain and edema. Research has shown that preoperative and postoperative melatonin administration can reduce postoperative pain and accelerate sensory recovery through its antioxidant effects.

Вмешательства

• Другое no intervention
  this group patients receive any medication for edema control.
• Другое lymphatic drainage massage
  A total of 10 sessions of lymphatic drainage massage will be applied to this group of patients, starting from the 2nd postoperative day, with 2 sessions per week.
• Пищевая добавка oral melatonin tablet
  In this group of patients, the first dose of 10 mg oral melatonin tablet will be given one day prior to the operation, and the patients will continue taking the tablet daily for a total of 21 days.
• Комбинированный продукт both melatonin and lymphatic drainage
  In this group of patients, a total of 10 sessions of lymphatic drainage massage will be applied starting from the 2nd postoperative day, with 2 sessions per week, while the first dose of 10 mg oral melatonin tablet will be administered one day prior to the operation, and the patients will continue taking the tablet daily for 21 days.

Первичные конечные точки

• Postoperative edema assessment [Срок оценки: 1month]

Вторичные конечные точки (1)

• pain assessment [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Patients with dentofacial deformities who are planned to undergo orthognathic surgery
• Patients who have not previously undergone orthognathic surgery
• Patients with no systemic diseases

Критерии исключения

• Presence of systemic diseases affecting general health
• Presence of malignant disease in the head and neck region
• Patients who have previously undergone orthognathic surgery
• Patients with any bleeding disorders
• Patients with cardiovascular disease who are under anticoagulant or antiplatelet therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Bezmialem Vakıf Universty — Istanbul

Идентификаторы

NCT: NCT07062757 · E-190312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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