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Symptoms of obstruction and dimensions of the nasal cavity after Surgically Assisted Rapid Maxillary Expansion with 2 and 3 segments: randomized clinical trial

Efficacy of Surgically Assisted Rapid Maxillary Expansion (SARME) with technique in two (2S) and three (3S) segments: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8rhkm25
Enrollment
Unknown
Registered
2022-06-22
Start date
2014-02-03
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

Anomalies of the relationship between the dental arches

Interventions

Fifty patients with transverse maxillary skeletal deficiency equal to or greater than 7 mm were randomized into 2 groups called 2S and 3S. In the group 2S, the technique of surgically assisted rapid m

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Adult patients, literate and without cognitive impairment. Present maxillary transverse skeletal deficiency equal to or greater than 7 mm. Distance between the roots of the lateral incisors and maxillary canines of at least 1.2 mm so that osteotomies could be performed if the patient was randomized to the group with 3-segment osteotomies.

Exclusion criteria

Exclusion criteria: Patients with unilateral transverse maxillary skeletal deficiency. Presence of congenital craniofacial syndromes. Surgeries previously performed on the maxilla or nose. Diagnosis of possible nasal alterations such as the deviated septum, hypertrophy of the nasal turbinates, polyps, etc. Patient who had the expander loosened during the activation or retention period. Patients who did not perform any of the postoperative exams in their respective periods of analysis.

Design outcomes

Secondary

MeasureTime frame
Outcome expected: It is expected to find an increase in the palate surface area evaluated through digitized files of plaster models of the maxilla used in a three-dimensional program (Geomagic Qualify 2013; Raindrop Geomagic, Inc, Morrisville, NC, USA).;Outcome found: An increase in the palate surface area was found postoperatively in relation to the preoperative period (p < 0.001) in both groups with no differences between them.

Primary

MeasureTime frame
Outcome expected 1: To evaluate the nasal obstruction symptoms through the application of the nasal obstruction symptoms evaluation scale (NOSE scale) applied preoperatively and up to 10 months after the surgical procedure. As it is clinical data, this outcome was considered the main outcome of the study and used for the sample calculation, requiring a total of 13 patients per study group. ;Outcome found 1: A decrease in the NOSE scale score was found between pre- and postoperative assessments in both study groups (p < 0.001), implying an improvement in nasal obstruction symptoms in a similar way in both study groups (p = 0.370).;Outcome expected 2: To evaluate the dimensions of the nasal cavity through acoustic rhinometry examination, identifying the volume and minimum cross-sectional area of the nasal cavity pre-operatively and up to 10 months after the surgical procedure.;Outcome found 2: The minimum cross-sectional area showed a non-significant increase (p = 0.203), however, suggesting important clinical relevance and together with the volume (p = 0.174) of the nasal cavities remained constant in both study groups.

Countries

Brazil

Contacts

Public ContactAlexandre da Silva

Universidade Federal de São Paulo

aafsilva@unifesp.br55 11 5576.4848 - Ramal: 3054

Outcome results

None listed

Source: REBEC (via WHO ICTRP)