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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

Evaluation of the preemptive and preventive use of coadministration of Ibuprofen l-arginine and Dexamethasone on postoperative inflammatory markers, quality of life, sleep quality and pain catastrophizing in lower third molar surgeries: a randomized, split-mouth, factorial, controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-4ht99zx
Enrollment
Unknown
Registered
2023-10-13
Start date
2022-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anomalies of tooth position

Interventions

This is a two-arm, triple-blind, split-mouth randomized controlled clinical study. There will be 48 patients, 24 in each group. Volunteers may be allocated into one of two groups, following a 2X2 fact
D27.505.954.329.030

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to 35 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactEdson Cetira Filho

Universidade Federal do Ceará

edson.cetira@hotmail.com+55-085-997219653

Outcome results

None listed

Source: REBEC (via WHO ICTRP)