Acute Dental PainPhase 4NCT06916234

Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain

A Phase 4 study testing Dexketoprofen Trometamol + Paracetamol and Naproxen Sodium + Codeine Phosphate in people with Acute Dental Pain, run by ibrahim doğru at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Acute dental pain is one of the most challenging conditions to treat and manage in dental practice. The aim of this study was to compare the efficacy of naproxen sodium + codeine phosphate (550/30 mg) and dexketoprofen trometamol + paracetamol (25/300 mg) in the treatment of acute dental pain in individuals with acute… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Acute Dental Pain
What is being tested?: Dexketoprofen Trometamol + Paracetamol and Naproxen Sodium + Codeine Phosphate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Jan 2023to 20 Jan 2024
Phase: Phase 4
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Individuals aged 18 and over
Individuals with systemic status ASA0 and ASA1 according to the American Society of Anaesthesiologists (ASA) classification,
Individuals with semi-erupted impacted lower third molar teeth associated with acute pericoronitis,
Individuals with a VAS score of 5 and above at the first visit.

Who cannot join

pregnant or lactating women,
smokers,
alcohol and/or drug users,
those who did not attend post-operative check-ups,
those who were using other than the recommended medication,
those who developed adverse drug reactions during the study and discontinued medication,
those who were allergic to the study drugs,
those who underwent additional dental treatment during the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Van Yuzuncu Yil University
Van, 65080

Other trials in Turkey (Türkiye)

About this study

Read the detailed description

This randomised, prospective, single-blind study was conducted on patients who presented to Van Yuzuncu Yil University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery between January 2023 and December 2023 with the complaint of acute pericoronitis originating from the lower impacted third molar teeth. At the first visit, the patients underwent a clinical examination to evaluated the patients' complaints, whether the complaints were caused by impacted lower third molar , and the presence of infection. For radiographic assessment, panoramic radiographs were taken of the region of the impacted lower third molars about which the patients complained. Patients who met the inclusion criteria were randomised into two groups, by the research assistants using the Research Randomizer (version 4.0) program to ensure blinding of the surgeons. Group A (active control group) received 550 mg naproxen sodium + 30 mg codeine phosphate and group B (research group) received 25 mg dexketoprofen trometamol + 300 mg paracetamol 2 times daily for 7 days; and amoxicillin 500 mg 3 times daily for 5 days in addition to analgesics for infection control due to acute pericoronitis. Paracetamol 500 mg was administered as rescue medication. Patients were instructed not to take rescue medication unless they had to and, if they did, to record the time and number of doses on the form given to them. Patients in the study groups received the first dose of the drugs from us and continued to receive subsequent doses every 12 hours.

A Visual Analogue Scale (VAS) with numbers ranging from 0 - no pain to 10 - un-bearable pain was used to evaluate pain. Patients were asked to record their VAS score on the form at the 6th hour (T1), 12th hour (T2), 18th hour (T3), 24th hour (T4), 2nd day (T5), 3rd day (T6), 4th day (T7), 5th day (T8), 6th day (T9) and 7th day (T10) after the first dose (T0 of study drug. Obtained data was analyzed and evaluated statistically.

Conditions: Acute Dental Pain
Being tested: Dexketoprofen Trometamol + Paracetamol, Naproxen Sodium + Codeine Phosphate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexketoprofen Trometamol + ParacetamolDrug
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.
Naproxen Sodium + Codeine PhosphateDrug
Naproxen Sodium + Codeine Phosphate (550mg + 30mg) is a NSAID. It was given to the patients twice a day.

Study groups in NCT06916234
Study group	Role	What they receive
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1)	Active comparator	Not described Receives: Drug: Dexketoprofen Trometamol + Paracetamol
Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1)	Active comparator	Not described Receives: Drug: Naproxen Sodium + Codeine Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 6th hour
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 12th hour
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 18th hour
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 24th hour
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 2nd day
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 3rd day
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 4th day
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 5th day
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 6th day
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Measured: 7th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202320 Jan 2024

First posted8 Apr 2025
Study start10 Jan 2023
Primary completion20 Dec 2023
Study completion20 Jan 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 Acute Dental PainStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06916234
Sponsor's protocol ID: 30.11.2022/07
Status last verified: Mar 2025
First submitted: 21 Mar 2025
Last updated: 8 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Dogru I, Cigerim L. Comparison of the analgesic efficacy of dexketoprofen trometamol and paracetamol with naproxen sodium and codeine phosphate combinations in acute toothache. Sci Rep. 2025 Oct 17;15(1):36381. doi: 10.1038/s41598-025-20361-7.
PubMed 41107344

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vital Pulp Therapy Versus Root Canal Treatment for Irreversible Pulpitis With Incipient Apical Periodontitis Diagnosed Using Artificial Intelligence This Keeps: the Main Intervention (Vital Pulp Therapy) the Comparison (Root Canal Treatment) the Condition (Irreversible Pulpitis With Incipient Apic
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All Acute Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain
ClinicalTrials.gov ID: NCT06916234
Acronym / sponsor ID: 30.11.2022/07
Conditions: Acute Dental Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: ibrahim doğruUniversity, hospital or other
Study start: 10 Jan 2023 (actual)
Primary completion: 20 Dec 2023 (actual)
Study completion: 20 Jan 2024 (actual)
First posted: 8 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1)	Active comparator	Drug: Dexketoprofen Trometamol + Paracetamol
Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1)	Active comparator	Drug: Naproxen Sodium + Codeine Phosphate

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Individuals aged 18 and over
Individuals with systemic status ASA0 and ASA1 according to the American Society of Anaesthesiologists (ASA) classification,
Individuals with semi-erupted impacted lower third molar teeth associated with acute pericoronitis,
Individuals with a VAS score of 5 and above at the first visit.

Key exclusion criteria (8 listed)

pregnant or lactating women,
smokers,
alcohol and/or drug users,
those who did not attend post-operative check-ups,
those who were using other than the recommended medication,

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 Trometamol + ParacetamolDexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.	Drug	Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1)
Naproxen Sodium + Codeine PhosphateNaproxen Sodium + Codeine Phosphate (550mg + 30mg) is a NSAID. It was given to the patients twice a day.	Drug	Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1)

Primary outcome

Pain Evaluation
Time frame: 6th hour
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 12th hour
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 18th hour
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 24th hour
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 2nd day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 3rd day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 4th day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 5th day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 6th day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Time frame: 7th day
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).

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 8 Apr 2025.
Derived from this study: PubMed 41107344Dogru I, Cigerim L. Comparison of the analgesic efficacy of dexketoprofen trometamol and paracetamol with naproxen sodium and codeine phosphate combinations in acute toothache. Sci Rep. 2025 Oct 17;15(1):36381. doi: 10.1038/s41598-025-20361-7.
Individual participant dataSharing planned: Undecided

Related trials for Acute Dental Pain

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Enrolling by invitation
Alternatives to Dental Opioid Prescribing After Tooth Extraction
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Active, not recruiting
Vital Pulp Therapy Versus Root Canal Treatment for Irreversible Pulpitis With Incipient Apical Periodontitis Diagnosed Using Artificial Intelligence This Keeps: the Main Intervention (Vital Pulp Therapy) the Comparison (Root Canal Treatment) the Condition (Irreversible Pulpitis With Incipient Apic
Symptomatic Irreversible Pulpitis
RecruitingObservational study
Bite Force Measurements
Irreversible Pulpitis, Apical Periodontitis

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.

ibrahim doğru Assist. Prof. principal investigator

ibrahimdogru@yyu.edu.tr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexketoprofen Trometamol + Paracetamol and Naproxen Sodium + Codeine Phosphate in people with Acute Dental Pain, run by ibrahim doğru at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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 8 Apr 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 Turkey (Türkiye). 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pain Evaluation (time frame: 6th hour). The study lists 10 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 NCT06916234, 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 8 Apr 2025.