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Analysis of dental and facial changes and nasal function in adults

Analysis of dentofacial changes and nasal function with two different bone-anchored maxillary expanders in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77018128
Enrollment
66
Registered
2023-05-02
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary deficiency in adults Oral Health

Interventions

Sample size will be determined with sequential statistical analysis with the cut-off for subject recruitment at 36 months. Experience gained from conducting a previous study at the University of Alber

Sponsors

University of Alberta
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Requirement of maxillary expansion treatment for the groups 2. Need for post-expansion orthognathic surgery 3. Full permanent dentition erupted (except 3rd molars) 4. Treatment may involve post-expansion tooth extraction or not 5. No syndromic characteristics or systematic diseases clinically determined or based on previous records 6. Male and female aged 18-30 years

Exclusion criteria

Exclusion criteria: Patients with palates too narrow for placement of the expander appliance, with large tori and/or asymmetric (canted) maxillary palatal plane

Design outcomes

Primary

MeasureTime frame
Skeletal and airway changes to measure expansion using cone-beam computed tomography (CBCT) images, dental scan, photos, airway measurements and questionnaires at baseline, 12 months, end of active treatment and end of retention at 2 years. Expansion is measured using CBCT images, and dental scans. Changes in nasal volume and shape obtained will be obtained from the CBCT images after applying the AVIZO software. Airway resistance and nasal peak airflow will be compared between groups and the association between airway resistance and nasal volume/shape is measured using CBCT and polysomnography.

Secondary

MeasureTime frame
Dental expansion changes measured using CBCT images, dental scans, photos, airway measures and questionnaires at baseline, 12 months, end of active treatment and end of retentions, questionnaires, etc.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026