Evaluation of the use before surgery of the combination of two drugs Ibuprofen l-arginine and Dexamethasone on postoperative inflammatory markers, quality of life, sleep quality and pain catastrophizing in lower third molar surgeries

Phase 2

• Conditions: Anomalies of tooth position; A14.549.167.860.525.500

• Registration Number: RBR-4ht99zx
• Lead Sponsor: niversidade Federal do Ceará

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-13
• Last Update Posted: 13 November 2023
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Healthy individuals of both sexes; aged between 18-35 years; in need of removal of the two lower third molars; will be invited to participate in this study. In addition to these, the following inclusion criteria will also be adopted: semi-erupted or non-erupted mandibular third molars; third molars that present, on panoramic radiography, similar patterns of root formation, position and degree of impaction when comparing the right and left sides of each volunteer

Exclusion Criteria

Volunteers who meet at least one of the following criteria will be excluded: smokers; pregnant or lactating women; users of medications that interact with the drugs used in this study; carriers of orthodontic bands in mandibular second molars; confirmed history of allergy to NSAIDs or corticoids; signs of any preoperative inflammatory or infectious condition; systemic diseases; neurological disorders. In addition, the volunteer who has used any NSAID or corticoid within a period of up to 21 days before the surgical procedure will also be excluded from the research due to the possibility of a residual effect of the drug eventually used, which may influence the outcomes of the present study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate mean differences in clinical parameters related to inflammatory events (pain, edema and trismus). Pain will be assessed through the visual analog scale; Edema will be measured by distances between specific points on the face; Trismus will be evaluated by measuring the mouth opening using a caliper.

Secondary Outcome Measures

Name	Time	Method
Evaluate the occurrence of quantitative changes in oxidative stress biomarkers, impact on quality of life, sleep quality and pain catastrophizing in patients during the postoperative period. Oxidative stress will be assessed by measuring specific biomarkers, such as nitrate, malondialdehyde and total protein. Quality of life will be assessed using a specific questionnaire, such as the Oral Health Impact Profile (OHIP-14); sleep quality through the Pittsburg Sleep Quality Index - PSQI23 and pain catastrophizing through a specific scale.