Trial Outcomes & Findings for Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE) (NCT NCT05446714)

NCT ID: NCT05446714

Last Updated: 2025-04-25

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-04-25

Participant Flow

orthodontic department al-azhar university

• 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.

Participant milestones

Measure	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	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	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
Overall Study STARTED	18	18	18
Overall Study COMPLETED	15	15	16
Overall Study NOT COMPLETED	3	3	2

Reasons for withdrawal

Measure	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	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	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
Overall Study Lost to Follow-up	1	3	2
Overall Study Protocol Violation	2	0	0

Baseline Characteristics

dropout due to bad oral hygiene

Baseline characteristics by cohort

Measure	Conventional Hyrax n=18 Participants 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	Hybrid Hyrax n=18 Participants 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	Maxillary Skeletal Expander n=18 Participants 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	Total n=54 Participants Total of all reporting groups
Age, Categorical s · <=18 years	6 Participants n=18 Participants • dropout due to bad oral hygiene	6 Participants n=18 Participants • dropout due to bad oral hygiene	6 Participants n=18 Participants • dropout due to bad oral hygiene	18 Participants n=54 Participants • dropout due to bad oral hygiene
Age, Categorical s · Between 18 and 65 years	6 Participants n=18 Participants • dropout due to bad oral hygiene	7 Participants n=18 Participants • dropout due to bad oral hygiene	6 Participants n=18 Participants • dropout due to bad oral hygiene	19 Participants n=54 Participants • dropout due to bad oral hygiene
Age, Categorical s · >=65 years	6 Participants n=18 Participants • dropout due to bad oral hygiene	5 Participants n=18 Participants • dropout due to bad oral hygiene	6 Participants n=18 Participants • dropout due to bad oral hygiene	17 Participants n=54 Participants • dropout due to bad oral hygiene
Age, Continuous	14.50 years STANDARD_DEVIATION 1.04 • n=18 Participants	13.96 years STANDARD_DEVIATION 1.21 • n=18 Participants	13.81 years STANDARD_DEVIATION 0.98 • n=18 Participants	14.09 years STANDARD_DEVIATION 1.07 • n=54 Participants
Sex: Female, Male Female	5 Participants n=18 Participants	6 Participants n=18 Participants	6 Participants n=18 Participants	17 Participants n=54 Participants
Sex: Female, Male Male	13 Participants n=18 Participants	12 Participants n=18 Participants	12 Participants n=18 Participants	37 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Conventional Hyrax n=15 Participants 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	Hybrid Hyrax n=15 Participants 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	Maxillary Skeletal Expander n=16 Participants 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
Molar Distance:	43.55 mm Standard Deviation 1.97	44.79 mm Standard Deviation 4.27	42.14 mm Standard Deviation 3.25

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Conventional Hyrax n=15 Participants 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	Hybrid Hyrax n=15 Participants 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	Maxillary Skeletal Expander n=16 Participants 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
Molar Inclination	5.66 mm Standard Deviation 1.52	4.85 mm Standard Deviation 2.10	2.08 mm Standard Deviation 1.30

SECONDARY outcome

Timeframe: 6 months

amount of maxillary width changes by CBCT Evaluation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

CBCT Evaluation

Outcome measures

Outcome data not reported

Adverse Events

Conventional Hyrax

Serious events: 1 serious events

Other events: 1 other events

Deaths: 15 deaths

Hybrid Hyrax

Serious events: 1 serious events

Other events: 1 other events

Deaths: 15 deaths

Maxillary Skeletal Expander

Serious events: 1 serious events

Other events: 2 other events

Deaths: 16 deaths

Serious adverse events

Measure	Conventional Hyrax n=18 participants at risk 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	Hybrid Hyrax n=18 participants at risk 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	Maxillary Skeletal Expander n=18 participants at risk 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
Metabolism and nutrition disorders metabolism	5.6% 1/18 • Number of events 2 • 6 months	5.6% 1/18 • Number of events 1 • 6 months	5.6% 1/18 • Number of events 2 • 6 months

Other adverse events

Measure	Conventional Hyrax n=18 participants at risk 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	Hybrid Hyrax n=18 participants at risk 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	Maxillary Skeletal Expander n=18 participants at risk 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
Cardiac disorders cardiac	5.6% 1/18 • Number of events 1 • 6 months	5.6% 1/18 • Number of events 2 • 6 months	11.1% 2/18 • Number of events 3 • 6 months

Additional Information

dr. mohamed shendy

al-azhar university

Phone: 01223303833

Email: Shendy_ortho@azhar.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place