RecruitingPhase 4ACTRN12619001709134

Analgesic efficacy when extracting lower third molars

Analgesic effectiveness of Tramadol/dexketoprofen (TRAM/DKP) compared with Ibuprofen in the impacted third molar extraction pain model.

Sponsor

María Cristina Vallecillo Rivas

Enrollment

68 participants

Start Date

Oct 17, 2019

Study Type

Interventional

Conditions

Third molar extraction

Summary

Clinical experience shows that, in the management of this type of pain of moderate-severe intensity, it is difficult to obtain effective analgesia with a single drug (monotherapy), and therefore combinations of analgesics are widely used to provide effective analgesia. (multimodal analgesia). The main hypothesis from which we start is that patients who are given Enanplus 75mg / 25mg will have less pain intensity and will need less rescue medication than those taking ibuprofen and will not present any significant adverse effects

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Having a wisdom tooth (lower third molar) removed is one of the most common dental surgeries performed, but the pain that follows can be significant. Managing pain after this procedure often requires combining different types of pain relief — a strategy called multimodal analgesia — because no single medication typically provides complete relief. This study is comparing a combined tablet called Enanplus (which contains 75mg of dexketoprofen and 25mg of tramadol) against ibuprofen alone for post-operative pain control after lower wisdom tooth extraction. The goal is to determine which approach provides better pain relief and requires less additional rescue medication. You may be eligible if you are a patient at the Master of Oral Surgery program seeking extraction of a lower wisdom tooth and you are otherwise in good health (ASA Class I). People who are pregnant or breastfeeding, have known allergies to the study medications, have taken antibiotics or analgesics in the 24 hours before surgery, or have a pre-existing infection around the wisdom tooth (pericoronitis) are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Assess the analgesic efficacy of Tramadol/dexketoprofen (TRAM/DKP) compared with Ibuprofen after the extraction of retained mandibular third molar. Patients will be divided into two groups based on a

Assess the analgesic efficacy of Tramadol/dexketoprofen (TRAM/DKP) compared with Ibuprofen after the extraction of retained mandibular third molar. Patients will be divided into two groups based on a randomization table. Group 1: it will be formed by thirty four patients. They will be given one tablet of Ibuprofen 400mg, 1 tablet every 8 hours during 48 h after extraction. Group 2: it will be formed by thirty four patients. They will be given one tablet of Enanplus 75mg/25 mg (tramadol 75 mg/dexketoprofen 25 mg), 1 tablet every 8 hours during 48 h after extraction. The extractions will be made by students of the Master of Oral Surgery and Implantology in the University of Granada.?Patients will be prescribed an antibiotic therapy consisting of amoxicillin 750 mg, 1 tablet every 8 hours for 6 days, for allergies to amoxicillin the antibiotic of choice will be clindamycin 300mg with the same regimen. Rescue medication consisted of 1g paracetamol if after 1 hour no effective analgesia was achieved with the given medication. To ensure compliance with the study, patients are given a data collection sheet and an information paper. Patients will also be called by phone to ensure compliance with the study and in case of any doubt.

Locations(1)

Granada, Spain

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