Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial

NCT07133360 — Not applicable, Completed, 12 participants, Universidad Complutense de Madrid

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Cocktail of Vitamin B, Vitamin D and Melatonine VS Ibuprofen in the Surgical Third Molar Extraction. Randomized Clinical Trial

Registry	NCT07133360, acronym CoctailRCT
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	12 (Actual)
Sponsor	Universidad Complutense de Madrid (Other)
Conditions	Swelling Lips &Amp; Face, Pain, Trismus
Interventions	Third molar extraction (Procedure)
Dates	start 2025-02-01, primary completion 2025-04-01, completion 2025-05-01, first posted 2025-08-21, last updated 2025-08-21
Locations	1 site in Spain

-Summary

Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction

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+Arms and interventions

Arm	Type	Interventions	Description
Ibuprofen 400	Active comparator	Procedure: Third molar extraction	Three ibuprofen 400 doses
Coctail mixed Drugs	Experimental	Procedure: Third molar extraction	Vitamin D, Vitamin B and Melatonine at night instead Ibuprofen

Third molar extraction (Procedure): Surgical third molar extraction with conventional medication

+Outcome measures

Primary outcomes

Post operative pain [10 DAYS]: VAS pain scale
Swelling [7 DAYS]: Face measurement for swelling
Trismus [7 DAYS]: Opening limitation

Secondary outcomes

Rescue analgesia [7 DAYS]: Need for more medications
Inflammatory profile [7 days]: Blood cytokines

+Eligibility

Sex: All, ages: 18 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy volunteers, non ibuprofen allergic, presence of impacted lower third molar

Exclusion Criteria:

* Diseases that avoid surgical intervention

+Locations (1)

Facility	City	Country	Status
Complutense University of Madrid	Madrid	Spain

+Publications

Results publication: Abusamak M, Perez-Gonzalez F, Ruiz LV, Saez-Alcaide LM, Al-Waeli H, Garcia-Denche JT, Marino FAT. Effect of NSAIDs, melatonin, vitamin D and vitamin B12 chronotherapy on postoperative recovery after third molar surgical extraction: A pilot randomized crossover placebo-controlled trial. Oral Maxillofac Surg. 2026 Jun 3;30(1):95. doi: 10.1007/s10006-026-01582-0. PMID 42230417

+Funding

NIH grants: 2019