Preoperative effect of 15 mg Melatonin on Anxiety, Pain, difficulty in mouth opening, Swelling, and Psychomotor Function in lower wisdom tooth Extraction: a randomized, double-blind, placebo-controlled clinical trial

Effect of preoperative use of 15mg Melatonin on Anxiety, Pain, Trismus, Edema and Psychomotor Function in lower third molar Extraction: a randomized double-blind, placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-7h4zchf

Enrollment

Unknown

Registered

2024-10-10

Start date

2024-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Interventions

This is a randomized controlled clinical trial with two groups and a double-blind design. A total of sixty people meeting the eligibility criteria will be randomly allocated to one of the intervention

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D03.633.100.473.914.481

Eligibility

Age

18 Years to 25 Years

Inclusion criteria

Inclusion criteria: Patients indicated for the extraction of at least one lower third molar (right or left); aged between 18 and 25 years; without systemic disease or who have a compensated systemic disease, classified as ASA I or ASA II (Classification by the American Society of Anesthesiologists); who agree to participate in the research in all its terms and sign the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: Patients who routinely or daily use melatonin, anxiolytics, antidepressants, neuroleptics, or other drugs acting on the Central Nervous System; those allergic to melatonin, local anesthetics, or rescue medications that cannot be substituted due to the proper conduct of the study; those using Fluvoxamine; presence of psychiatric problems; blood pressure greater than or equal to 160x100 mmHg; pregnant and/or lactating women; classified as ASA III or ASA IV (Classification by the American Society of Anesthesiologists); surgeries exceeding 45 minutes after anesthetic infiltration; third molars classified as high difficulty; patients who withdrew their consent to participate in the research; patients who did not return for the seven-day postoperative follow-up or failed to submit the postoperative evaluation diary

Design outcomes

Primary

Measure	Time frame
It is expected to observe, through the analysis of the applied questionnaires, that the use of 15mg sublingual melatonin in a single preoperative dose produces beneficial effects, such as reduced anxiety, transoperative and postoperative pain, trismus and postoperative edema, lack of psychomotor and cognitive impairment, and improvement or no alteration in postoperative sleep quality, providing comfort and safety to the surgical procedure, consistent with clinical observations and self-reports	—

Measure

Time frame

It is expected to observe, through the analysis of the applied questionnaires, that the use of 15mg sublingual melatonin in a single preoperative dose produces beneficial effects, such as reduced anxiety, transoperative and postoperative pain, trismus and postoperative edema, lack of psychomotor and cognitive impairment, and improvement or no alteration in postoperative sleep quality, providing comfort and safety to the surgical procedure, consistent with clinical observations and self-reports

—

Secondary

Measure	Time frame
No secondary outcomes are expected	—

Countries

Brazil

Contacts

Public ContactMarcelo Bortoluzzi

Universidade Estadual de Ponta Grossa

mbortoluzzi@gmail.com+55(42)99114 9794

Outcome results

None listed

Source: REBEC (via WHO ICTRP)