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Efficacy of Bromelain in controlling pain, edema and trismus after third molar extractions

Comparative analysis of the effectiveness of Bromelain versus Ibuprofen in the control of pain, edema and trismus after toohth extractions

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-858cd68
Enrollment
Unknown
Registered
2025-08-05
Start date
2023-09-15
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

Inflammation

Interventions

This is a randomized, triple-blind, split-mouth clinical trial in which 19 participants will be recruited, each undergoing two surgical procedures (P1 and P2) with a minimum interval of three weeks be
Test Group 2 will receive 600 mg of ibuprofen orally every 8 hours for three days). To randomize the surgical side, the research team will provide two opaque envelopes, each containing a slip of paper

Sponsors

Universidade de Pernambuco - Multicampi Garanhuns
Lead Sponsor
Universidade de Pernambuco - Reitoria
Collaborator

Eligibility

Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Indication of complicated extractions or bilateral lower third molars; teeth indicated for extraction must present the same degree of difficulty for removal; participants of both sexes; participants must be between 18 and 35 years old; healthy participants (ASA I) and with controlled systemic diseases (ASA II); absence of infectious process at the surgical site; not having used antimicrobials, anti-inflammatories or analgesics in the last two weeks

Exclusion criteria

Exclusion criteria: Participants allergic to nonsteroidal anti-inflammatory drugs, bromelain derivatives, and dipyrone; patients with missing upper and lower incisors or prostheses due to the impossibility of measuring mouth opening; patients with a history of blood dyscrasias or chronic pain; smokers

Design outcomes

Primary

MeasureTime frame
The assessment of pain intensity will be measured using the VAS (Visual Analog Scale) , a numeric scale with 11 points, starting at point zero (no pain) and ending at point 10 (maximum possible pain). The evaluation will be performed by the patient after 2h, 4h, 6h, 8h, 12h, 24h, 72h and 7 days after surgery. The means and standard deviations of each group will be calculated (test 1 and test 2). Pain will also be assessed indirectly by the number of rescue pills taken by the patient in the postoperative period.

Secondary

MeasureTime frame
The edema will be evaluated with the help of a measuring tape. Three measurements will be performed on the patient using 5 reference points: (A) Corner of eye/angle of jaw; (B) tragus/corner of the mouth; (C) tragus/pogonion. Measurements will be performed in the preoperative period (baseline) and after 24, 72 h and 7 days after surgery. The edema evolution will be obtained by subtracting the total value of each postoperative period (average of the three values) and the average of the preoperative period (baseline).;To measure the parameters of mandibular trismus, the Maximum Mouth Opening without assistance (distance between the upper and lower left central incisor) will be taken, performed by a single examiner, using a digital caliper duly calibrated and measured with the results described in millimeters. . Trismus will be calculated by the difference between the pre- and postoperative interincisal distances, with measurements taken after 24, 72 hours and 7 days.;It will be measured seven days after the procedure using the Likert scale (1 to 5) in order to measure the participant's satisfaction with the procedure performed, with 1 being very dissatisfied; 2, dissatisfied; 0, has no opinion; 3, satisfied; and 4, very satisfied.

Countries

Brazil

Contacts

Public ContactRenata Almeida

Universidade de Pernambuco

renata.albuquerquea@upe.br+55 (081) 991442695

Outcome results

None listed

Source: REBEC (via WHO ICTRP)