Clinical trial NCT06812026: Effects of Melatonin and Massage After Third Molar Surgery
Official title: Comparison of the Effects of Melatonin and Lymphatic Drainage Massage on Pain, Edema, and Mouth Opening Following Impacted Third Molar Extraction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melatonin
Keywords: edema
tooth removal
melatonin
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: who need impacted tooth removal surgery in the rutine clinic patients

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients need for removal surgery of impacted third molars.
2. Patients without systemic diseases.

Exclusion Criteria:

1. Presence of systemic diseases affecting general health.
2. Presence of a malignant disease in the head and neck region.
3. Patients with any bleeding disorders.
4. Patients with cardiovascular diseases or those undergoing anticoagulant or antiplatelet therapy.

Primary outcomes:
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.
timeFrame: postoperative 7 days
Secondary outcomes:
measure: 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.
timeFrame: postoperative 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Universty
state: Fatih
Study officials:
References: