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

NCT07062757 | Enrolling By Invitation

• 1 other identifier: E-190312
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentofacial Deformities; Edema; Pain

Keywords

dentafacial deformities; edema; pain

Outcome Measures

Primary Outcomes (1)

• 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.

  1month

Secondary Outcomes (1)

• pain assessment

  1 month

Study Arms (4)

group 1 (No intervention)

SHAM COMPARATOR

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

Other: no intervention

group 2 (lymphatic drainage massage)

EXPERIMENTAL

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

group 3 (oral melatonin tablet)

EXPERIMENTAL

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

group 4 (both melatonin and lymphatic drainage)

EXPERIMENTAL

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

Interventions

no intervention OTHER

this group patients receive any medication for edema control.

group 1 (No intervention)

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.

group 2 (lymphatic drainage massage); group 4 (both melatonin and lymphatic drainage)

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.

group 3 (oral melatonin tablet); group 4 (both melatonin and lymphatic drainage)

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.

group 4 (both melatonin and lymphatic drainage)

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentofacial Deformities; Edema; Pain

Interventions

Manual Lymphatic Drainage; Melatonin

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 14, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

TU (1)