Using melatonin before wisdom tooth surgery to reduce pain and medication use
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery
This study is testing if taking melatonin for three nights before wisdom tooth surgery can help reduce pain and the need for pain medication after the procedure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT04791943 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of melatonin administered for three nights prior to wisdom tooth extraction in reducing postoperative pain and the need for pain medication. Participants will be randomly assigned to receive either melatonin or a placebo, and various factors such as pre-operative anxiety, sleep quality, and post-operative pain levels will be measured. The goal is to determine if melatonin can improve recovery outcomes for patients undergoing this common dental procedure.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-35 with impacted third molars requiring surgical extraction.
Not a fit: Patients with allergies to melatonin or opioids, sleep disorders, or those with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced pain and lower reliance on narcotics after wisdom tooth surgery.
How similar studies have performed: While the use of melatonin for pain management is being explored, this specific application in dental surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation * Ages 18-35 * ASA Class I or II * English or Spanish speaking patients * Capacity to sign informed consent Exclusion Criteria: * Allergies to melatonin, opioids, or other OTC pain medications * Anyone currently taking melatonin for any reason * Cases under local anesthesia * ASA class III or higher * Sleep disorder (insomnia/narcolepsy) * Current or past history of substance abuse * Chronic pain * Language/communication barrier * Psychiatric disease/ Mental impairment * Current or past use of psychotropic drugs * Pregnancy * Renal or hepatic impairment * BMI \>35
Where this trial is running
Bronx, New York
- Montefiore Medical Center Department of Dentistry — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jason Baker, DMD — Montefiore Medical Center
- Study coordinator: Charles K Levin, DDS
- Email: montefioreomfs@gmail.com
- Phone: 718-904-8190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.