Actively Recruiting
Three-dimensional Analysis of Palatal Morphology in Growing Children With Posterior Cross-bite Treated Using Rapid Palatal Expander
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-03
36
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying changes in the shape of the palate in growing children with different vertical facial growth patterns who have a posterior cross-bite. The study focuses on patients with mixed dentition, skeletal Class I relationship, and who are in the prepubertal stage. The goal is to understand how rapid palatal expander treatment affects the palate morphology among hyperdivergent, hypodivergent, and normodivergent facial types. The treatment involves using a rapid palatal expander device for about 6 months. Patients will be grouped based on their facial divergence patterns. Digital dental casts will be recorded before and after the treatment using an intraoral scanner. Researchers will perform linear measurements and a comprehensive study of the palate shape using a set of 240 landmarks and semi-landmarks. Geometric Morphometric Analysis (GMA) will compare the palate shape changes among the different groups. Participants will undergo clinical evaluations and have pre-treatment and post-treatment digital records including oral scans and photographs. The primary outcome is to measure morphological changes of the palate after 6 months. Secondary outcomes include detailed shape analysis of the palatal vault among the different facial types. The study requires good quality records and informed consent from participants, with total participation lasting around 6 months.
CONDITIONS
Brief Title
3D Analysis of Palatal Morphology of Growing Patients Treated With Rapid Palatal Expander.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caucasian origin
- Mixed dentition stage
- Angle class I or straight step or mesial step molar relationship in primary dentition
- Skeletal class I (ANB angle between 0° and 5°)
- Vertical facial growth patterns classified as hyperdivergent (SN^GoGn > 37°), hypodivergent (SN^GoGn < 27°), or normodivergent (SN^GoGn between 27° and 37°)
- Cervical vertebral stage 1 or 2
- Posterior cross-bite including deciduous or permanent teeth
- Presence of good quality pre-treatment records including history, intraoral and extraoral photos, oral scan, panoramic and lateral cephalometric radiographs with reference ruler
- Oral scan and photographs available 6 months after treatment start
- Signed informed consent form
You will not qualify if you...
- Previous orthodontic treatment
- Tooth agenesis or supernumerary teeth
- Craniofacial abnormalities
- Tooth impaction in the maxilla
- Torus palatinus
- History of dental trauma such as avulsion or jaw fracture
- Refusal to sign consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 6 months
Participants receive treatment with a rapid palatal expander device.
Regular visits during the 6-month treatment period
Duration - 6 months
Participants are observed to assess morphological changes of the palate after device treatment.
Follow-up assessments including oral scans and photographs
Trial Site Locations
Total: 1 location
1
UOC Clinica Odontoiatrica, Fondazione Poli..
Roma, Italy, 00168
Actively Recruiting
Research Team
M
Massimo Cordaro
A
Angelica Guastamacchia
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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