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Comparison between two types of medications for pain and swelling control after wisdom teeth removal

Evaluation of two drug regimens in the levels of PGE2 after surgical extraction of third molars

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-23chpws
Enrollment
20
Registered
2026-02-11
Start date
2015-01-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Tooth Extraction

Interventions

This is a prospective, randomized, double-blind, split-mouth clinical trial. A total of 20 participants who meet the eligibility criteria will be included in the study. Each participant will undergo t

Sponsors

Faculdade de Odontologia de Piracicaba – Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 30 years; ASA I (American Society of Anesthesiologists physical status classification I); Presence of mandibular third molars in similar positions; Not using any medication routinely or within the week prior to the study; No known allergy to the drugs used in the study; Surgical site without current signs or symptoms of infection.

Exclusion criteria

Exclusion criteria: Patients with a history of pregnancy or lactation; History of gastrointestinal bleeding or peptic ulcer; Allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs); Patients under continuous use of psychoactive drugs, analgesics, or steroidal and nonsteroidal anti-inflammatory agents; Smokers; Presence of postoperative infection signs or symptoms.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 A significant difference in postoperative pain intensity between pharmacological regimens is expected, assessed using the Visual Analog Scale (VAS), based on a minimum difference of 2 points on a 0–10 scale at 2, 6, 12, 24, 48, and 72 hours after surgery.;Observed outcome 1 A statistically significant difference in postoperative pain intensity between pharmacological regimens was observed only at 2 hours after surgery, with higher pain scores reported in the dexamethasone group compared to the nimesulide group (p = 0.0222), assessed using the Visual Analog Scale (VAS). No significant differences were observed at the other evaluated time points.;Expected outcome 2 A significant difference in postoperative facial swelling between pharmacological regimens is expected, assessed through standardized linear facial measurements, based on a minimum difference of 5% at 3 and 7 days after surgery.;Observed outcome 2 No statistically significant differences were observed between pharmacological regimens in postoperative facial swelling, measured using standardized linear facial measurements, at 3 and 7 days after surgery (p = 0.6938).;Expected outcome 3 A significant difference in postoperative limitation of mouth opening between pharmacological regimens is expected, assessed by measuring maximum interincisal distance with a millimeter ruler, based on a minimum difference of 5 mm at 3 and 7 days after surgery.;Observed outcome 3 No statistically significant differences were observed between pharmacological regimens regarding postoperative limitation of mouth opening, assessed by maximum interincisal distance, at 3 and 7 days after surgery (p = 0.7484).

Secondary

MeasureTime frame
Expected outcome 4 A significant difference in salivary prostaglandin E2 (PGE2) levels between pharmacological regimens is expected, assessed using the ELISA method, based on percentage variation in PGE2 levels at the preoperative period, immediate postoperative period, and at 3 and 7 days after surgery.;Observed outcome 4 No statistically significant differences were observed in salivary prostaglandin E2 (PGE2) levels between pharmacological regimens at any evaluated time point (p > 0.05). A significant increase in PGE2 levels was observed in the nimesulide group at 7 days compared to 3 days after surgery (p = 0.0279), without associated clinical relevance.

Countries

Brazil

Contacts

Public ContactRenato Ribeiro

Faculdade de Odontologia de Piracicaba – Universidade Estadual de Campinas

renato.ribeiro@ufpi.edu.br+55(86)981867807

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026