Dentofacial DeformitiesNCT07062757
Lymphatic Drainage Massage and Melatonin in Post-Orthognathic Surgery Pain and Edema
A study testing lymphatic drainage massage, oral melatonin tablet and both melatonin and lymphatic drainage in people with Dentofacial Deformities and Edema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities, Edema, Pain
- What is being tested?
- lymphatic drainage massage, oral melatonin tablet and both melatonin and lymphatic drainage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with dentofacial deformities who are planned to undergo orthognathic surgery
- Patients who have not previously undergone orthognathic surgery
- Patients with no systemic diseases
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bezmialem Vakıf Universty
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Lymphatic Drainage Massage and Melatonin on Pain and Edema After Orthognathic Surgery.
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.
Read the 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.
- Conditions
- Dentofacial Deformities, Edema, Pain
- Being tested
- no intervention, lymphatic drainage massage, oral melatonin tablet, both melatonin and lymphatic drainage
- Keywords
- dentafacial deformities, edema, pain
- Medical subject headings
- Dentofacial Deformities, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this group patients receive any medication for edema control.
lymphatic drainage massageOther
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 tabletDietary 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 drainageCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 (No intervention) | Sham comparator | No intervention will be applied to prevent edema in this group of patients. Receives: 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 Receives: 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. Receives: 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. Receives: Other: lymphatic drainage massage; Dietary Supplement: oral melatonin tablet; Combination Product: both melatonin and lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1month
Secondary outcomes (1)
pain assessment
VAS assessment will be performed on all days when edema measurements are taken for pain evaluation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start30 Mar 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062757
- Sponsor's protocol ID
- E-190312
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lymphatic Drainage Massage and Melatonin on Pain and Edema After Orthognathic Surgery.
- ClinicalTrials.gov ID
- NCT07062757
- Acronym / sponsor ID
- E-190312
- Conditions
- Dentofacial Deformities, Edema, Pain
- Keywords
- dentafacial deformities, edema, pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 (No intervention) | Sham comparator | Other: no interventionNo intervention will be applied to prevent edema in this group of patients. |
| group 2 (lymphatic drainage massage) | Experimental | Other: lymphatic drainage massageIn 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 |
| group 3 (oral melatonin tablet) | Experimental | Dietary Supplement: oral melatonin tabletIn 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. |
| group 4 (both melatonin and lymphatic drainage) | Experimental | Other: lymphatic drainage massage, Dietary Supplement: oral melatonin tablet, Combination Product: both melatonin and lymphatic drainageIn this group of patients, both melatonin and lymphatic drainage procedures will be applied together. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with dentofacial deformities who are planned to undergo orthognathic surgery
- Patients who have not previously undergone orthognathic surgery
- Patients with no systemic diseases
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthis group patients receive any medication for edema control. | Other | group 1 (No intervention) |
| lymphatic drainage massageA 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. | Other | group 2 (lymphatic drainage massage), group 4 (both melatonin and lymphatic drainage) |
| oral melatonin tabletIn 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. | Dietary supplement | group 3 (oral melatonin tablet), group 4 (both melatonin and lymphatic drainage) |
| both melatonin and lymphatic drainageIn 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. | Combination product | group 4 (both melatonin and lymphatic drainage) |
Primary outcome
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.
1 secondary outcome
pain assessment
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphatic drainage massage, oral melatonin tablet and both melatonin and lymphatic drainage in people with Dentofacial Deformities and Edema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative edema assessment (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.