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Comparative analysis of anti-inflammatory effect of two drugs administered previously surgery to remove wisdom teeth

Comparative analysis of anti-inflammatory effect of a corticosteroid and a NSAID administered previously to impacted thrid molars surgery: a randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-8w8yh8
Enrollment
Unknown
Registered
2017-09-19
Start date
2017-04-17
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

Postoperative Complications, Postoperative Pain, Edema, Trismus, Unerupted Tooth

Interventions

The study will be compound by two groups, a test group and a control group. An amount of 40 individuals will take part in this research. Each participant will be submited to two surgeries and will tak
Drug
D03.438.473.420.742

Sponsors

Universidade de Pernambuco, Campus Arcoverde
Lead Sponsor
Universidade de Pernambuco, Campus Arcoverde
Collaborator

Eligibility

Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes; Aging between 18 e 35 years in the moment of the intervetion; Have indication for surgical removal of four third molars with total or parcial bony impaction; Have the right and left third molars in similar position according to Pell and Gregory and Winter classifications; Be at least 10 days without using any drug that influences significantly the inflammatory response; and agree with the terms of the research.

Exclusion criteria

Exclusion criteria: Have any disease or systemic condition that contraindicate the surgical procedure; Continually use drugs that influences significantly the inflammatory response; Be in gestation or lactation; Show signals and symptons of inflammation or infection related to third molars at the moment of the intervention; Total duration of the surgical procedure longer than 90 minutes in any of the interventions; Have, during the surgical procedure, any unusual complication that results in the break of the protocol estabilished in the material and methods of the study; and refuse to participate of the data collection procedures.

Design outcomes

Primary

MeasureTime frame
Postoperative pain: The pain will be measured by a Visual Analogue Scale (VAS) containing color scale, face scale and pain level, which varies from 1 to 10. The patients will be guided to measure the pain in 8-hour intervals during the first 72 hours after the surgical procedure. Swelling: The swelling will be assessed by metering some reference points in the patient's face. The following reference points will be measured: a)Distance from the angle of the mandible to tragus; b)Distance from the angle of the mandible to lateral palpebral commissure; c)Distance from the angle of the mandible to ala of the nose; d)Distance from the angle of the mandible to labial commissure of mouth; The quantification of swelling will be characterized by the ratio between the values obtained in 24, 48 and 72 hours of the postoperative period and the basal values. Trismus: The trismus will be measured by the interincisal distance, in milimeters, during the maximum mouth open. This measure will be assessed by a calibrated digital pachymeter, using the incisal border of the left central incisors (superior and inferior) as reference. The trismus will be determined by the difference between the basal value and the values obtained in the 24, 48 and 72 hours of the postoperative period.

Secondary

MeasureTime frame
Rate of rescue medication consuption in the postoperative period, assessed by the amount of pill consumed in the first seven days after surgery.

Countries

Brazil

Contacts

Public ContactFábio da Costa Araújo

Universidade de Pernambuco, Campus Arcoverde

fabio.andrey@upe.br+558738221051

Outcome results

None listed

Source: REBEC (via WHO ICTRP)