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Search / Trial NCT04730297

Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Jan 25, 2021

Trial Information

Current as of August 02, 2025

Completed

Keywords

Postsurgical Dental Pain

ClinConnect Summary

Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paraceta...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • healthy status (ASA class I);
  • nonsmoker;
  • not pregnant or breastfeeding;
  • no medication consumption in the past 21 days;
  • good oral hygiene;
  • bony impaction of one mandibular third molars;
  • the presence of the first and second molars;
  • compliance to cooperate with the research protocol.
  • Exclusion Criteria:
  • chronic systemic disease;
  • medications with potential interaction to paracetamol-codeine or ibuprofen;
  • a history of intolerance or hypersensitivity to the study drugs;
  • any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.

About University Of Roma La Sapienza

The University of Roma La Sapienza, one of Italy's premier research institutions, is dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in diverse fields, including medicine, biotechnology, and public health, to conduct rigorous and ethically sound research. Committed to fostering educational excellence and promoting groundbreaking discoveries, La Sapienza actively engages in clinical trials that aim to address critical health challenges and contribute to the development of new therapeutic interventions.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Maria Paola Cristalli, DDS, PhD

Principal Investigator

University of Roma La Sapienza

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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