MelatoninNCT06812026
Effects of Melatonin and Massage After Third Molar Surgery
An observational study of Melatonin, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Lymphatic drainage massage is an important practice, especially for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin surface. It accelerates the flow of lymph fluid and provides comfort by minimizing swelling. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Melatonin
- What is being tested?
- no melatonin and massage, receive melatonin and receiving lymphatic drainage
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 10 May 2026
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: who need impacted tooth removal surgery in the rutine clinic patients
Who may be able to join
- Patients need for removal surgery of impacted third molars.
- Patients without systemic diseases.
Who cannot join
- Presence of systemic diseases affecting general health.
- Presence of a malignant disease in the head and neck region.
- Patients with any bleeding disorders.
- Patients with cardiovascular diseases or those undergoing anticoagulant or antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf Universty
Istanbul, Fatih, 34093
About this study
Official title: Comparison of the Effects of Melatonin and Lymphatic Drainage Massage on Pain, Edema, and Mouth Opening Following Impacted Third Molar Extraction
Lymphatic drainage massage is an important practice, especially for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin surface. It accelerates the flow of lymph fluid and provides comfort by minimizing swelling. Lymphatic drainage massage, which is frequently used after impacted third molar surgery, helps reduce edema and increases patient comfort during the postoperative period.
Melatonin, a hormone produced by the pineal gland, is a neurochemical substance that works in harmony with the body's natural rhythm. In addition to the brain, it is found in the retina, bone marrow, intestines, skin, and various blood cells. Conditions such as insomnia or jet lag may benefit from melatonin supplements. Besides contributing to sleep quality, melatonin may also assist in regulating the immune system, body temperature, blood pressure, and cortisol hormone levels.
Read the detailed description
Another important function of melatonin is that it is a very powerful free radical scavenger. Melatonin can neutralize both reactive oxygen species and reactive nitrogen species. It is also known to capture highly toxic hydroxyl radicals, peroxynitrite anions, and peroxyl radicals. In some cases, melatonin inhibits nitric oxide synthase, a prooxidant enzyme. Additionally, it stimulates the mRNA levels of superoxide dismutase enzyme and is known to activate glutathione peroxidase, glutathione reductase, and glucose-6-phosphate dehydrogenase. After reacting with the hydroxyl free radical (OH•), melatonin transforms into an indolyl cation radical, which is noted to capture the superoxide radical (O2 · -) in the environment and exhibit antioxidant activity. Due to this powerful antioxidant property, its effects on pain and edema have been investigated in some studies. In these studies, pre-op/post-op melatonin application has been shown to reduce postoperative pain and accelerate sensory healing due to melatonin's antioxidant effects.
- Conditions
- Melatonin
- Being tested
- no melatonin and massage, receive melatonin, receiving lymphatic drainage
- Keywords
- edema, tooth removal, melatonin
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no melatonin and massageOther
receiving no melatonin and massage
receive melatoninDietary supplement
receiving only melatıonin pills
receiving lymphatic drainageOther
receiving lymphatic drainage massage
| Study group | Role | What they receive |
|---|---|---|
| control | during the postoperative period receive any lymphatic drainage massage and melatonin Receives: Other: no melatonin and massage | |
| study melatonin | during the postoperative period receive only melatonin pills Receives: Dietary Supplement: receive melatonin | |
| study lymphatic drainage massage | during the postoperative period receive only lymphatic drainage massage Receives: Other: receiving lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
melatonin effect on edema: Postoperative edema will be measured preoperatively and on the 3rd and 7th days. Distances between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded with a thread.
during the post operative periods patients receive melatonin pill until 7 days
Measured: postoperative 7 days
Secondary outcomes (1)
Lymphatic drainage massage effect on edema: Postoperative edema will be measured preoperatively and on the 3rd and 7th days. Distances between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded with a thread.
during the post operative periods patients receive lymphatic drainage massage until 7 days
Measured: postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2025
- Primary completion1 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812026
- Sponsor's protocol ID
- E.173684
- Status last verified
- Jun 2025
- First submitted
- 27 Jan 2025
- Last updated
- 24 Jun 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Melatonin and Lymphatic Drainage Massage on Pain, Edema, and Mouth Opening Following Impacted Third Molar Extraction
- ClinicalTrials.gov ID
- NCT06812026
- Acronym / sponsor ID
- E.173684
- Conditions
- Melatonin
- Keywords
- edema, tooth removal, melatonin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 6 Feb 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 an important practice, especially for reducing edema. It is a very gentle, monotonous, slow, rhythmic massage applied to the skin surface. It accelerates the flow of lymph fluid and provides comfort by minimizing swelling. Lymphatic drainage massage, which is frequently used after impacted third molar surgery, helps reduce edema and increases patient comfort during the postoperative period.
Melatonin, a hormone produced by the pineal gland, is a neurochemical substance that works in harmony with the body's natural rhythm. In addition to the brain, it is found in the retina, bone marrow, intestines, skin, and various blood cells. Conditions such as insomnia or jet lag may benefit from melatonin supplements. Besides contributing to sleep quality, melatonin may also assist in regulating the immune system, body temperature, blood pressure, and cortisol hormone levels.
Detailed description
Another important function of melatonin is that it is a very powerful free radical scavenger. Melatonin can neutralize both reactive oxygen species and reactive nitrogen species. It is also known to capture highly toxic hydroxyl radicals, peroxynitrite anions, and peroxyl radicals. In some cases, melatonin inhibits nitric oxide synthase, a prooxidant enzyme. Additionally, it stimulates the mRNA levels of superoxide dismutase enzyme and is known to activate glutathione peroxidase, glutathione reductase, and glucose-6-phosphate dehydrogenase. After reacting with the hydroxyl free radical (OH•), melatonin transforms into an indolyl cation radical, which is noted to capture the superoxide radical (O2 · -) in the environment and exhibit antioxidant activity. Due to this powerful antioxidant property, its effects on pain and edema have been investigated in some studies. In these studies, pre-op/post-op melatonin application has been shown to reduce postoperative pain and accelerate sensory healing due to melatonin's antioxidant effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: no melatonin and massageduring the postoperative period receive any lymphatic drainage massage and melatonin |
| study melatonin | – | Dietary Supplement: receive melatoninduring the postoperative period receive only melatonin pills |
| study lymphatic drainage massage | – | Other: receiving lymphatic drainageduring the postoperative period receive only lymphatic drainage massage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- who need impacted tooth removal surgery in the rutine clinic patients
Key inclusion criteria (2 listed)
- Patients need for removal surgery of impacted third molars.
- Patients without systemic diseases.
Key exclusion criteria (4 listed)
- Presence of systemic diseases affecting general health.
- Presence of a malignant disease in the head and neck region.
- Patients with any bleeding disorders.
- Patients with cardiovascular diseases or those undergoing 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 melatonin and massagereceiving no melatonin and massage | Other | control |
| receive melatoninreceiving only melatıonin pills | Dietary supplement | study melatonin |
| receiving lymphatic drainagereceiving lymphatic drainage massage | Other | study lymphatic drainage massage |
Primary outcome
melatonin effect on edema: Postoperative edema will be measured preoperatively and on the 3rd and 7th days. Distances between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded with a thread.
Time frame: postoperative 7 days
during the post operative periods patients receive melatonin pill until 7 days
1 secondary outcome
Lymphatic drainage massage effect on edema: Postoperative edema will be measured preoperatively and on the 3rd and 7th days. Distances between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded with a thread.
Time frame: postoperative 7 days
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 24 Jun 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. This study is not recruiting at the moment.
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?
An observational study of Melatonin, 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 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. 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?
melatonin effect on edema: Postoperative edema will be measured preoperatively and on the 3rd and 7th days. Distances between the gonion-lateral canthus and tragus-labial commissure will be measured and recorded with a thread. (time frame: postoperative 7 days). 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 24 Jun 2025.