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Efficacy of Selegiline Chloridate in the treatment of changes Nervous due to Surgery for Corrections in the Maxilla and Mandible

Efficiency of Selegiline Chloridate in treating Neurosensory Disturbances Arising from Orthognic Surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-685dmr
Enrollment
Unknown
Registered
2020-03-19
Start date
2019-09-02
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

Skin paresthesias / Orthognathic surgery

Interventions

To determine the data of this research, a structured form with objective questions will be used, filled out by the researcher himself, based on reports from patients who have undergone orthognathic su
Drug
D02.092.471.683.915
HP3.073.433.101
G11.561.585

Sponsors

Universidade de Pernambuco
Lead Sponsor
comissão de aperfeiçoamento de pessoal de nível superior
Collaborator
Universidade de Pernambuco
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both sexes aged between 18 and 40 years; patients undergoing bimaxillary orthognathic surgery to correct class II dentofacial deformity with mandibular advancement not exceeding 7 mm; those who do not have third molars (18,28, 38 and 48) or who have been completely removed at least six months before surgery. Those who agree with the research and sign the free and informed consent form; patients who report not having sensorineural disorders before surgery; not having autoimmune syndromes or diseases; patients who do not have pre-diagnosed psychiatric or psychological disorders; patients who do not have heart disease, liver disease, rheumatological, diabetic or chronic kidney problems; not having basic diseases that alter the patient's sensory perceptions; those who do not have the presence of wounds or dermatological pathologies on the face, which may impair the application of the tests proposed in this study; patients who do not use controlled medication or who, through drug interaction, contraindicate the use of any of the therapies proposed in this study; patients who do not have allergies to the drugs of interest in this research; women who are not pregnant or breastfeeding.

Exclusion criteria

Exclusion criteria: Those who do not have any sensorineural changes in the postoperative period; Patients who have an unwanted fracture or visible rupture of the lower alveolar nerve during the operation; patients who, during the operation, present abnormal bleeding or are at risk of developing pseudoaneurysms; those that, during the operation, it is necessary to fix the segments only with bicortical screws or in a hybrid form (plate and monocortical screws plus bicortical screw); patients who, at the operator's option, need maxillomandibular block in the postoperative period; individuals who have developed any postoperative infection at the surgery site; patients who develop any allergies or unwanted effects related to selegiline hydrochloride; participants who experience episodes of vomiting or any discomfort that has not been remedied with protective medication; those who happen to present some alteration in the hemodynamic, hepatic and / or renal parameters, which will be evaluated periodically during the research through laboratory tests of control; participants who, for whatever reason, spontaneously wish to give up participating in the research; those who do not comply or who do not attend all stages of the research; women who are pregnant or breastfeeding during the research.

Design outcomes

Primary

MeasureTime frame
Recovery of sensory perception of the face measured by testing two static points with a minimum distance of 5mm between the points, at the end of the 90 days after surgery.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactBruno Mesquita

Universidade de Pernambuco

brunomesquitajpa@hotmail.com55-81-31847661

Outcome results

None listed

Source: REBEC (via WHO ICTRP)