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Evaluation of the use of medications in wisdom tooth extraction surgeries

Drug evaluation in third molar surgeries. Blind, randomized clinical trial in divided mouth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4yq8n9
Enrollment
Unknown
Registered
2020-03-16
Start date
2019-02-01
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

Edema

Interventions

The aim of this study will be to evaluate drug therapy in patients undergoing extraction of lower third molars, semi-included or included, in relation to the reduction of signs and symptoms inherent t
Drug

Sponsors

Instituto de Ciência e Tecnologia - Câmpus de São José dos Campos
Lead Sponsor
Instituto de Ciência e Tecnologia - Câmpus de São José dos Campos
Collaborator

Eligibility

Age
15 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients in need of extraction of third molars, regardless of gender; presence of teeth in opposite hemiarchs with similar positions; patients aged between 15 and 40 years; patients who voluntarily agree to participate in the research, being aware of the risks and benefits, and signing the Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: Patients with local or systemic changes that contraindicate the procedure; use of anti-inflammatory drugs in the last 15 days; presence of lower third molars in different position and classification of inclusion on both sides; erupted lower third molars; patients allergic to amoxicillin.

Design outcomes

Primary

MeasureTime frame
The expected primary outcome will be the absence of statically significant changes in view of the differences between making use of antibiotic therapy in patients undergoing extraction of the lower included third molars, with the data being assessed during the postoperative period, where the patients themselves undergoing the procedure will note on the analogue pain scale (VAS) the painful experience that may be contained between the parameters: zero, for “no pain”, and ten, for “worst possible pain”, in which subjective pain assessments will be performed throughout postoperative period, until the third day.;Facial edema will be measured using the technique described by Ustün et al. (2003) based on the distance between the lateral corner of the eye and the gonion, the distance from the tragus to the labial commissure and the distance from the tragus to the soft tissue of the pogonion. The measurements on each side must be added in the preoperative period to obtain a baseline value that will be compared to the sum of the same distances in the postoperative period, thus evidencing the presence and magnitude of the edema present in each of the periods in which assessments will be made. The measurements will be made with a flexible ruler in the period of three and seven days. No statistically significant differences are expected between the groups analyzed.;The mouth opening will be measured in the preoperative period and later on the third and seventh day. For the measurements to be made, the patients must be seated, erect and a millimeter ruler will be positioned between the incisal edges of the upper and lower central incisors. No statistically significant differences are expected between the groups analyzed.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactIvan Oliveira

Instituto de Ciência e Tecnologia - Câmpus de São José dos Campos

ivan.oliveira@me.com+55-12-39479000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)