ClinicalTrials.Veeva

Menu

Patient Education Before Orthognathic Surgery

U

University of Sao Paulo

Status

Completed

Conditions

Malocclusion
Micrognathism
Anxiety
Prognathism

Treatments

Other: Booklet - Preoperative Educational

Study type

Interventional

Funder types

Other

Identifiers

NCT01803204
193.454

Details and patient eligibility

About

To evaluate the effectiveness in the use of an educational material through: Assessment of knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management of postoperative signs and symptoms

Full description

It is a clinical randomized controlled trial being developed from February 2013 to September 2015, divided into two phases: a pilot study without randomization for impact testing and evaluation of intervention and, in the second time, the clinical randomized study with possible changes after the pilot study.

Will be entered in the study patients undergoing maxillofacial surgery originating at outpatient clinic located in the municipality of São Paulo. The study aims to evaluate the effects of educational material in postoperative education orthognathic surgery, with intervals between pre and postoperative serials.

Recruitment plan of patients: the patients seen in oral and maxillofacial surgery and traumatology clinic located in the municipality of São Paulo with indication for orthognathic surgery will be covered by personally and invited to participate in intervention research. To control the bias will be included in the study patients of the same surgical team, to ensure the same surgical technique and postoperative guidance conduct by the surgeon.

Study variables: it is intended to analyse the socio-demographic variables: sex, age, level of education; independent variables: surgical technique, recovery time, difficulties experienced during the postoperative period, possible surgical complications; dependent variables: signs and symptoms postoperatively (presence or absence) and monitoring of care during the postoperative period; level of knowledge about the post-op of orthognathic surgery and anxiety levels (State-trait anxiety inventory-IDATE).

Enrollment

48 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing orthognathic surgery during the study and with surgical technique:

    • sagittal maxillary bilateral osteotomy;
    • maxillary;
    • vertical osteotomy;
    • Lefort I osteotomy combined with or without mentoplastia and maxillary disjunction.
  • Informed consent

  • Patients in the maxillofacial outpatient clinic located at Sao Paulo

Exclusion criteria

  • patients undergoing reoperation of orthognathic surgery;
  • with cleft lip-palate.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Booklet - Preoperative Educational
Experimental group
Description:
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
Treatment:
Other: Booklet - Preoperative Educational
Control
No Intervention group
Description:
This group don't received booklet, they will be monitored during the postoperative period to control

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems