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N/A N=40 Randomized Double-blind Health Services Research

Patient Education Before Orthognathic Surgery

Malocclusion · Anxiety · Micrognathism · Prognathism

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Patients With Clinical Changes During the Postoperative Recovery — 10; 10 participants — p=1.00

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Booklet - Preoperative Educational (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Sao Paulo
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Clinical Changes During the Postoperative Recovery
10; 10 1.00
SECONDARY
Average Test Arrangements on Surgery
6.5; 4.3; 6.8; 5.0; 7.00; 5.20 <0.01 sig

Summary

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

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01803204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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