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Enrolling by Invitation

NCT Number: NCT07062757

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

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.

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Key information

Conditions

Dentofacial Deformities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Edema Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

No intervention

Other

this group patients receive any medication for edema control.

lymphatic drainage massage

Other

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.

oral melatonin tablet

Dietary Supplement

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.

both melatonin and lymphatic drainage

Combination Product

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.

Primary outcomes

  1. Postoperative edema assessment

    Time frame: 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 outcomes

  1. pain assessment

    Time frame: 1 month

    VAS assessment will be performed on all days when edema measurements are taken for pain evaluation.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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