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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 pericoronitis caused by impacted wisdom teeth.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1) | Active Comparator |
| |
| Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexketoprofen Trometamol + Paracetamol | Drug | Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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). | 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ibrahim doÄŸru Assist. Prof. | ibrahimdogru@yyu.edu.tr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University | Van | 65080 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41107344 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2023 |
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| Naproxen Sodium + Codeine Phosphate | Drug | Naproxen Sodium + Codeine Phosphate (550mg + 30mg) is a NSAID. It was given to the patients twice a day. |
|
| 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). | 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). | 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). | 7th day |
| Mar 31, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2023 | Mar 21, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D000082 | Acetaminophen |
| D009288 | Naproxen |
| D003061 | Codeine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
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