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Evaluation of pain, edema and trismus; oxidative stress markers and quality of life in mandibular third molar surgeries under different preemptive analgesia protocols: randomized clinical trial.

Evaluation of clinical parameters, oxidative stress markers, and quality of life in mandibular third molar surgeries under different preemptive analgesia protocols: randomized, factorial, clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9m4bh7
Enrollment
Unknown
Registered
2019-09-04
Start date
2019-06-03
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

There will be 40 patients, 20 in each group. Individuals will be allocated to whether or not they use nimesulide 100mg, 1 hour prior to the surgical procedure (placebo-controlled). To provide the 2X2
Drug
E02.594

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 (American Society of Anesthesiologists - ASA I) of both genders; aged 18-35 years; who are required to remove the lower third molars; will be invited to participate in this study. In addition, the following inclusion criteria will also be adopted: (1) third unerupted mandibular molars; (2) third molars that present, in 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: Will be excluded volunteers who meet at least one of the following criteria: history of photosensitivity; smokers; pregnant or lactating; users of medications that interact with drugs used in this study; patients with orthodontic bands in mandibular second molars; confirmed history of NSAID allergy; signs of any pre-operative inflammatory or infectious condition; systemic diseases; neurological disorders. In addition, the volunteer who has used any NSAID within a period of up to 21 days prior to the surgical procedure will also be excluded from the study because of the possibility of residual residual anti-inflammatory effects, 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
To evaluate the occurrence of quantitative changes in biomarkers of oxidative stress and impact on patients' quality of life regarding the postoperative period. Oxidative stress will be assessed by measuring specific biomarkers such as myeloperoxidase, n-acetyl-beta-D-glycosaminidase, malonaldehyde and glutathione. Quality of life will be assessed through specific questionnaires such as the Oral Health Impact Profile (OHIP-14) and the Health-Related Quality of Life (HRQOL).

Countries

Brazil

Contacts

Public ContactEdson Cetira Filho

Universidade Federal do Ceará

edson.cetira@hotmail.com5585997219653

Outcome results

None listed

Source: REBEC (via WHO ICTRP)