An interventional study of no intervention and lymphatic drainage massage in Dentofacial Deformities, Edema and Pain, sponsored by Bezmialem Vakif University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Prevention
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.
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.
40 studies on the registry are indexed under Dentofacial Deformities; 16 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 25 interventional studies indexed under Dentofacial Deformities.
Browse Dentofacial Deformities studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
No intervention will be applied to prevent edema in this group of patients.
Other: no intervention
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
Other: lymphatic drainage massage
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.
Dietary Supplement: oral melatonin tablet
In this group of patients, both melatonin and lymphatic drainage procedures will be applied together.
Other: lymphatic drainage massage · Dietary Supplement: oral melatonin tablet · Combination Product: both melatonin and lymphatic drainage
this group patients receive any medication for edema control.
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.
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.
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.
Postoperative edema assessment
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.
Time frame: 1month
pain assessment
VAS assessment will be performed on all days when edema measurements are taken for pain evaluation.
Time frame: 1 month
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
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Studies of the drug tested here: Melatonin