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CompletedNCT07133360CoctailRCTUpdated Aug 21, 2025

Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial

An interventional study of Third molar extraction in Swelling Lips &Amp; Face, Pain and Trismus, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2025, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Swelling Lips &Amp; Face
  • Pain
  • Trismus

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Keywords

  • Vitamin B
  • Vitamin D
  • Melatonine
  • Ibuprofen
  • Third Molar
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 12 is below the median of 66 across 8,493 interventional studies indexed under Pain.

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Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diseases that avoid surgical intervention
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Ibuprofen 400

    Three ibuprofen 400 doses

    Procedure: Third molar extraction

  • Experimental
    Coctail mixed Drugs

    Vitamin D, Vitamin B and Melatonine at night instead Ibuprofen

    Procedure: Third molar extraction

Interventions

  • ProcedureThird molar extraction

    Surgical third molar extraction with conventional medication

06

What researchers measure

Primary outcomes

  1. Post operative pain

    VAS pain scale

    Time frame: 10 DAYS

  2. Swelling

    Face measurement for swelling

    Time frame: 7 DAYS

  3. Trismus

    Opening limitation

    Time frame: 7 DAYS

Secondary outcomes

  1. Rescue analgesia

    Need for more medications

    Time frame: 7 DAYS

  2. Inflammatory profile

    Blood cytokines

    Time frame: 7 days

07

Study locations

1 site
  • Complutense University of Madrid
    Madrid, Spain
08

References and documents

Publications

  • 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. PubMed 42230417 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07133360
Lead sponsor
Universidad Complutense de Madrid
Responsible party
Jesús Torres García Denche (Doctor, Universidad Complutense de Madrid) — Principal investigator
First posted
Aug 21, 2025
Start date
Feb 1, 2025
Primary completion
Apr 1, 2025
Completion
May 1, 2025
Last update
Aug 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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