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Comparison of the effects of the Invisalign Palatal Expander (IPE) and the Hyrax Expander in the treatment of narrow maxilla

Effects of treatment of Maxillary Atresia in the mixed dentition with the Invisalign Palatal Expander (IPE) system and Hyrax expander: a randomized clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3yyd4jd
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-07-01
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

Orthodontics, Interceptive

Interventions

The study will be a parallel randomized clinical trial, and participants will be randomly allocated to two groups using simple randomization. In the IPE group (n=25), Invisalign Palatal Expander syste

Sponsors

Universidade Anhaguera - UNIDERP
Lead Sponsor
Universidade Anhaguera - UNIDERP
Collaborator

Eligibility

Age
7 Years to 10 Years

Inclusion criteria

Inclusion criteria: Ages 7 to 10 years; both sexes; Angle Class I malocclusion; presence of maxillary atresia; erupted upper and lower permanent incisors

Exclusion criteria

Exclusion criteria: Patients with craniofacial deformities; dental agenesis; history of previous orthopedic/orthodontic treatment

Design outcomes

Primary

MeasureTime frame
The primary expected outcome will be correction of maxillary atresia. To this end, the transverse measurements of the maxilla will be evaluated, as described below: Intercanine Distance (IC): linear distance between the tips of the cusps of the upper deciduous canines; Distance between First Deciduous Molars (DD): linear distance between the tips of the mesiobuccal cusps of the upper first deciduous molars; Distance between Second Deciduous Molars (DE): linear distance between the mesiobuccal cusps of the upper second deciduous molars; Distance between First Permanent Molars (D6): linear distance between the mesiobuccal cusps of the upper and lower permanent first molars; Arch Perimeter (AP): length of a line passing through the mesial surface of the upper permanent first molars, the mesial surface of the upper deciduous canines, and the mesial surface of the central incisors; Arch Depth (AD): length of a perpendicular line constructed from the mesial contact points of the central incisors to a line connecting the mesial contact points of the first permanent molars; Intermolar Angle (AIM): angle formed by the intersection between the two planes passing through the mesiobuccal, mesiopalatal, and distobuccal cusps of both upper first molars. Overlay of 3D digital maxillary models using the palatal ridges as a reference area.

Secondary

MeasureTime frame
The expected secondary results will be the similarity in the aspects evaluated in the two treatment groups, such as: pain and discomfort, sleep and wakefulness bruxism behavior, sleep quality and obstructive sleep apnea/hypopnea syndrome, oral health-related quality of life (OHRQoL), satisfaction with treatment, oral health literacy of those responsible, anxiety of the child's caregivers). In addition, we expect similarity in oral function will also be evaluated; occlusal contacts; cephalometric characteristics; presence of bacterial plaque; orofacial motricity and speech production and/or perception; cooperation; color stability of Invisalign expanders and complications.

Countries

Brazil

Contacts

Public ContactPaula Oltramari

Universidade Anhaguera - UNIDERP

pvoltramari@hotmail.com+55(67)3348-8452

Outcome results

None listed

Source: REBEC (via WHO ICTRP)