Maxillary Retrusion, Nasal Airway Obstruction
Conditions
Brief summary
Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).
Detailed description
Abstract Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT). Material and Methods: A total sample of thirty CBCT of patients presented with constricted maxilla with mean age of 14±3Y was randomized in to three groups. Group 1 CH, group 2 HH and group 3 MSE. CBCT records were taken before(T1) and after six months (T2) of RME; the Airway was segmented and quantified using software (version 5.3.4.39USA).
Interventions
DEVICECH 4 band
expansion of maxilla and observation improvement of the air way
DEVICEHH 2 bands
expansion of maxilla and observation improvement of the air way
DEVICEMSE 2 bands and 4
expansion of maxilla and observation improvement of the air way
Sponsors
World Health Organization
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering maxillary collapse with a skeletal background * Patients with unilateral or bilateral posterior crossbite. * Patients with reduced or average anterior face height. * Patients with no periodontal disease. * Patients with good oral hygiene and general health. * No systemic diseases that may affect bone quality or interfere with orthodontic treatment. * Patients with erupted maxillary permanent first molars and premolars. * Patients with no previous orthodontic treatment.
Exclusion criteria
* previous treatment * syndromes * cleft lip and palate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molar Distance: | 6 months | distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Molar Inclination | 6 months | amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation |
| Maxillary Width | 6 months | amount of maxillary width changes by CBCT Evaluation |
| Temporomandibular Joint | 6 months | CBCT Evaluation |
Countries
Egypt
Participant flow
Recruitment details
orthodontic department al-azhar university
Pre-assignment details
* Patients suffering maxillary collapse with a skeletal background * Patients with unilateral or bilateral posterior crossbite. * Patients with reduced or average anterior face height. * Patients with no periodontal disease. * Patients with good oral hygiene and general health.6- No systemic diseases that may affect bone quality or interfere with orthodontic treatment. * Patients with erupted maxillary permanent first molars and premolars.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Hyrax CH 4 BANDS for expansion of maxilla and observation improvement of the air way
CH 4 band: expansion of maxilla and observation improvement of the air way | 18 |
| Hybrid Hyrax HH 2 BANDS for expansion of maxilla and observation improvement of the air way
HH 2 bands: expansion of maxilla and observation improvement of the air way | 18 |
| Maxillary Skeletal Expander MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way
MSE 2 bands and 4: expansion of maxilla and observation improvement of the air way | 18 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 | 2 |
| Overall Study | Protocol Violation | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Conventional Hyrax | Hybrid Hyrax | Maxillary Skeletal Expander | Total |
|---|---|---|---|---|
| Age, Categorical s <=18 years | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Age, Categorical s >=65 years | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
| Age, Categorical s Between 18 and 65 years | 6 Participants | 7 Participants | 6 Participants | 19 Participants |
| Age, Continuous | 14.50 years STANDARD_DEVIATION 1.04 | 13.96 years STANDARD_DEVIATION 1.21 | 13.81 years STANDARD_DEVIATION 0.98 | 14.09 years STANDARD_DEVIATION 1.07 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 12 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 15 / 18 | 15 / 18 | 16 / 18 |
| other Total, other adverse events | 1 / 18 | 1 / 18 | 2 / 18 |
| serious Total, serious adverse events | 1 / 18 | 1 / 18 | 1 / 18 |
Outcome results
Primary
Molar Distance:
distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hyrax | Molar Distance: | 43.55 mm | Standard Deviation 1.97 |
| Hybrid Hyrax | Molar Distance: | 44.79 mm | Standard Deviation 4.27 |
| Maxillary Skeletal Expander | Molar Distance: | 42.14 mm | Standard Deviation 3.25 |
Secondary
Maxillary Width
amount of maxillary width changes by CBCT Evaluation
Time frame: 6 months
Secondary
Molar Inclination
amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Hyrax | Molar Inclination | 5.66 mm | Standard Deviation 1.52 |
| Hybrid Hyrax | Molar Inclination | 4.85 mm | Standard Deviation 2.1 |
| Maxillary Skeletal Expander | Molar Inclination | 2.08 mm | Standard Deviation 1.3 |
Secondary
Temporomandibular Joint
CBCT Evaluation
Time frame: 6 months