A Clinical Trial on comparing the anxiolytic effects of melatonin in patients indicated for third molar extraction surgery.

Oral Melatonin versus Placebo as an Anxiolytic Agent for Reducing Preoperative Anxiety in Impacted Third Molar Surgery Under Local Anesthesia: a Double-Blinded Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100222

Enrollment

Registered

2026-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

None listed

Interventions

Intervention1: Melatonin 10 mg tablet given via oral route: Melatonin tablet will be given via oral route 40 minutes prior to start of the procedure of Surgical extraction of mandibular third molar an

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 65 years. Patients with American Society of Anesthesiologists (ASA) Physical Status I or II. Patient having Generalised Anxiety Disorder-7 (GAD-7) Score ranging from 0-14. Patients requiring surgical removal of at least one impacted mandibular third molar. Patients who provide written informed consent to participate. Patients willing to follow study protocols, including preoperative medication intake.

Exclusion criteria

Exclusion criteria: Patients with significant systemic diseases (ASA III or higher). Patients on renal dialysis; with autoimmune disease; organ transplant recipients. Patients using anxiolytic drugs such as benzodiazepines, ciprofloxacin, sedatives, antidepressants, or melatonin supplements within the past 2 weeks. Patients with diagnosed sleep disorders such as insomnia. A patient screened to have a GAD-7 score of 15-21. A patient having first HAM-A score of 0-4. History of alcohol or drug dependence. Pregnant or breastfeeding women. Patients with cognitive impairment or inability to understand. Patients with known hypersensitivity to melatonin

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of preoperative oral melatonin administration in reducing anxiety levels compared to a placebo in patients undergoing impacted third molar extraction surgery under local anesthesiaTimepoint: 40 minutes after giving melatonin or placebo	—

Secondary

Measure	Time frame
To assess whether pre-operative melatonin improves patient cooperation scores during outpatient minor surgery against a placeboTimepoint: 15 Minutes after the start of surgery.	—

Countries

India

Contacts

Public ContactDr Nakul Uppal

All India Institute of Medical Sciences, Raipur

nakuluppal@aiimsraipur.edu.in9845628027

Outcome results