Swelling Lips &Amp; FaceCoctailRCTNCT07133360
Combination of Mixed Drugs vs Ibuprofen: a Randomized Clinical Trial
A study testing Third molar extraction in people with Swelling Lips &Amp; Face and Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Swelling Lips &Amp; Face, Pain, Trismus
- What is being tested?
- Third molar extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, non ibuprofen allergic, presence of impacted lower third molar
Who cannot join
- Diseases that avoid surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cocktail of Vitamin B, Vitamin D and Melatonine VS Ibuprofen in the Surgical Third Molar Extraction. Randomized Clinical Trial
Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction
- Conditions
- Swelling Lips &Amp; Face, Pain, Trismus
- Being tested
- Third molar extraction
- Keywords
- Vitamin B, Vitamin D, Melatonine, Ibuprofen, Third Molar
- Medical subject headings
- Facies, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar extractionProcedure or surgery
Surgical third molar extraction with conventional medication
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 400 | Active comparator | Three ibuprofen 400 doses Receives: Procedure: Third molar extraction |
| Coctail mixed Drugs | Experimental | Vitamin D, Vitamin B and Melatonine at night instead Ibuprofen Receives: Procedure: Third molar extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
VAS pain scale
Measured: 10 DAYS
Swelling
Face measurement for swelling
Measured: 7 DAYS
Trismus
Opening limitation
Measured: 7 DAYS
Secondary outcomes (2)
Rescue analgesia
Need for more medications
Measured: 7 DAYS
Inflammatory profile
Blood cytokines
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Feb 2025
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Swelling Lips &Amp; FaceStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Torres García Denche, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133360
- Sponsor's protocol ID
- 2019-000736-27
- Other IDs
- 2019
- Acronym
- CoctailRCT
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocktail of Vitamin B, Vitamin D and Melatonine VS Ibuprofen in the Surgical Third Molar Extraction. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07133360
- Acronym / sponsor ID
- CoctailRCT / 2019-000736-27
- Conditions
- Swelling Lips &Amp; Face, Pain, Trismus
- Keywords
- Vitamin B, Vitamin D, Melatonine, Ibuprofen, Third Molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combination of vitamins and melatonine compared with the conventional use of ibuprofen after surgical third molar extraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 400 | Active comparator | Procedure: Third molar extractionThree ibuprofen 400 doses |
| Coctail mixed Drugs | Experimental | Procedure: Third molar extractionVitamin D, Vitamin B and Melatonine at night instead Ibuprofen |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers, non ibuprofen allergic, presence of impacted lower third molar
Key exclusion criteria (1 listed)
- Diseases that avoid surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Third molar extractionSurgical third molar extraction with conventional medication | Procedure or surgery | Coctail mixed Drugs, Ibuprofen 400 |
Primary outcome
Post operative pain
Time frame: 10 DAYS
VAS pain scale
Swelling
Time frame: 7 DAYS
Face measurement for swelling
Trismus
Time frame: 7 DAYS
Opening limitation
2 secondary outcomes
Rescue analgesia
Time frame: 7 DAYS
Inflammatory profile
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 42230417Abusamak 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar extraction in people with Swelling Lips &Amp; Face and Pain, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 10 DAYS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.