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

Not Applicable

• Conditions: Dentofacial Deformities; Edema; Pain

• Registration Number: NCT07062757
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2025-03-30
• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-03-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative edema assessment	1month	Postoperative edema measurements will be taken after the patient is anesthetized before surgery and on the 1st, 3rd, and 7th postoperative days. Before the surgery, the gonion and tragus will be marked with methylene blue, and the distance between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded using a thread. Measurements will be repeated on postoperative days 1, 3, 7, 14, 21, and 28 and recorded in the evaluation form.

Secondary Outcome Measures

Name	Time	Method
pain assessment	1 month	VAS assessment will be performed on all days when edema measurements are taken for pain evaluation.

Trial Locations

Locations (1)

Bezmialem Vakıf Universty; 🇹🇷 Istanbul, Fatih, Turkey