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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-01-20

Brief Summary

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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.

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Detailed Description

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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

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Acute Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1)

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol + Paracetamol

Intervention Type DRUG

Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.

Naproxen Sodium + Codeine Phosphate (550 mg + 30 mg, 2X1)

Group Type ACTIVE_COMPARATOR

Naproxen Sodium + Codeine Phosphate

Intervention Type DRUG

Naproxen Sodium + Codeine Phosphate (550mg + 30mg) is a NSAID. It was given to the patients twice a day.

Interventions

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Dexketoprofen Trometamol + Paracetamol

Dexketoprofen Trometamol + Paracetamol (25mg + 300mg) is a NSAID. It was given to the patients twice a day.

Intervention Type DRUG

Naproxen Sodium + Codeine Phosphate

Naproxen Sodium + Codeine Phosphate (550mg + 30mg) is a NSAID. It was given to the patients twice a day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes