Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain
Phase: PHASE4
Conditions: Acute Dental Pain
Sponsor: ibrahim doğru

10.01.2023 
 
Evaluation of the analgesic efficacy of the combination of deksketoprofen + paracetamol and 
the combination of naproxen sodium + codeine in patients with acute dental pain 
İbrahim Doğru1, Levent Ciğerim 1  
1 Van Yuzuncu Yil University, Faculty of Dentistry, Department of Oral and Maxillofacial 
Surgery, Van, TURKEY 
Corresponding author: İbrahim Doğru 
 
Address: Van Yuzuncu Yil University, Faculty of Dentistry, Department of Oral and Maxillofacial 
 
Surgery, Van, Turkey Postal Code: 65080 
 
E-mail address: ibrahimdogru@yyu.edu.tr Phone:+905418952655 Office Phone: 904322251744 
 
Fax: +904322251747 
İbrahim DOĞRU 
 
Van Yuzuncu Yil University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery 
ibrahimdogru@yyu.edu.tr, +905418952655, https://orcid.org/0000-0001-9174-9401  
 
 
Levent CİĞERİM 
 
Van Yuzuncu Yil University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery 
leventcigerim@yyu.edu.tr, +905321633287, https://orcid.org/0000-0001-5218-8568 

Study Protocol, Methods and Procedures to be Applied: 
The study is planned to be carried out on 90 patients aged 18 and over, who applied to 
Van Yuzuncu Yil University, Faculty of Dentistry, Department of Oral and Maxillofacial 
Surgery, with complaints of acute pericoronitis caused by lower half impacted wisdom teeth. 
When patients first apply to the clinic, their anamnesis and demographic information will be 
obtained through anamnesis form. Patients who meet the inclusion criteria and volunteer will 
be included in the study.  
Patients will be randomly divided into 2 groups. Medications will be given to patients 
by auxiliary staff and the study will be double-blind. 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 assess 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 will be analyzed and evaluated statistically. 
 
 
Statistical Data Analysis: 
Descriptive statistics for continuous variables in our study; As Average, Standard 
Deviation, Minimum and Maximum values; will be expressed as numbers and percentages for 
categorical variables. Mann-Whitney U analysis will be used to compare group means in 
terms of continuous independent variables. In addition, the Wicoxon test will be calculated in 
the comparison of double dependent groups. In order to determine the relationship between 
these variables, Spearman correlation coefficients will be calculated separately for the groups. 
Chi-square test will be used to determine the relationship between groups and categorical 
variables. Statistical significance level will be taken as 5% in calculations and SPSS statistical 
package program will be used for calculations.