Tooth, ImpactedNCT05176158
Dexketoprofen Dosage According to Chronotherapy
A study testing Dexketoprofen 25 MG in people with Tooth, Impacted and Trismus, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted, Trismus, Pain
- What is being tested?
- Dexketoprofen 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2024to 1 Nov 2024
- 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
- Bilateral impacted lower third molar
Who cannot join
- NSAID allergic
- Contraindication of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.
The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock
Read the detailed description
A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.
- Conditions
- Tooth, Impacted, Trismus, Pain, Inflammatory Response
- Being tested
- Dexketoprofen 25 MG
- Keywords
- Third, Dexketroprofen, Randomized
- Medical subject headings
- Tooth, Impacted, Trismus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen 25 MGDrug
Also called Morning dosage
Pill at morning
Dexketoprofen 25 MGDrug
Also called Night dosage
Pill at night
| Study group | Role | What they receive |
|---|---|---|
| Morning dosage | Experimental | Dexketoprofen pill at morning; Placebo at night Receives: Drug: Dexketoprofen 25 MG |
| Night dosage | Experimental | Placebo pill at morning; Dexketoprofen at night Receives: Drug: Dexketoprofen 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operatory pain
Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))
Measured: From the day of the surgical procedure to the seventh-day
Secondary outcomes (1)
Swelling
Distance from tragus to pogonion
Measured: Baseline and post operatory (day 1, day 3, day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Nov 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
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 Tooth, ImpactedStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Jesús Torres García Denche, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176158
- Sponsor's protocol ID
- 2019-000736-26
- Other IDs
- 2019
- Status last verified
- Oct 2022
- First submitted
- 14 Dec 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Gonzalez F, Abusamak M, Ruiz LV, Saez-Alcaide LM, Al-Waeli H, Tamimi F, Garcia-Denche JT. Dexketoprofen Time-Dependent Administration After Third Molar Extraction: A Pilot Randomized Cross-Over Controlled Trial. Clin Exp Dent Res. 2026 Feb;12(1):e70163. doi: 10.1002/cre2.70163.
PubMed 41510697
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
- ClinicalTrials.gov ID
- NCT05176158
- Acronym / sponsor ID
- 2019-000736-26
- Conditions
- Tooth, Impacted, Trismus, Pain, Inflammatory Response
- Keywords
- Third, Dexketroprofen, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 4 Jan 2022 (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.
Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.
The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock
Detailed description
A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.
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 |
|---|---|---|
| Morning dosage | Experimental | Drug: Dexketoprofen 25 MGDexketoprofen pill at morning; Placebo at night |
| Night dosage | Experimental | Drug: Dexketoprofen 25 MGPlacebo pill at morning; Dexketoprofen at night |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Bilateral impacted lower third molar
Key exclusion criteria (2 listed)
- NSAID allergic
- Contraindication of surgery
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 |
|---|---|---|
| Dexketoprofen 25 MGAlso: Morning dosagePill at morning | Drug | Morning dosage |
| Dexketoprofen 25 MGAlso: Night dosagePill at night | Drug | Night dosage |
Primary outcome
Post operatory pain
Time frame: From the day of the surgical procedure to the seventh-day
Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))
1 secondary outcome
Swelling
Time frame: Baseline and post operatory (day 1, day 3, day 7)
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 4 Dec 2024.
- Derived from this study: PubMed 41510697Perez-Gonzalez F, Abusamak M, Ruiz LV, Saez-Alcaide LM, Al-Waeli H, Tamimi F, Garcia-Denche JT. Dexketoprofen Time-Dependent Administration After Third Molar Extraction: A Pilot Randomized Cross-Over Controlled Trial. Clin Exp Dent Res. 2026 Feb;12(1):e70163. doi: 10.1002/cre2.70163.
- Individual participant dataSharing planned: No
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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 Dexketoprofen 25 MG in people with Tooth, Impacted and Trismus, 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 2 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 4 Dec 2024. 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 operatory pain (time frame: From the day of the surgical procedure to the seventh-day). 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 NCT05176158, 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 4 Dec 2024.