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

Bezmialem Vakif University

Status: Invitation-only

Conditions: Edema; Dentofacial Deformities; Pain

Treatments: Other: no intervention; Other: lymphatic drainage massage; Dietary Supplement: oral melatonin tablet; Combination Product: both melatonin and lymphatic drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT07062757

E-190312

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with dentofacial deformities who are planned to undergo orthognathic surgery
2. Patients who have not previously undergone orthognathic surgery
3. Patients with no systemic diseases

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

group 1 (No intervention)

Sham Comparator group

Description:

No intervention will be applied to prevent edema in this group of patients.

Treatment:

Other: no intervention

group 2 (lymphatic drainage massage)

Experimental group

Description:

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

Treatment:

Other: lymphatic drainage massage

group 3 (oral melatonin tablet)

Experimental group

Description:

In this group of patients, the first dose of 10 mg oral melatonin tablet will be administered one day before the operation, and the patients will take the tablet daily for a total of 21 days.

Treatment:

Dietary Supplement: oral melatonin tablet

group 4 (both melatonin and lymphatic drainage)

Experimental group

Description:

In this group of patients, both melatonin and lymphatic drainage procedures will be applied together.

Treatment:

Combination Product: both melatonin and lymphatic drainage

Dietary Supplement: oral melatonin tablet

Other: lymphatic drainage massage