3D Evaluation of Maxillary Expansion Methods
Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods
1 other identifier
interventional
60
1 country
1
Brief Summary
This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2025
CompletedFirst Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 4, 2025
December 1, 2025
6 months
November 21, 2025
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Maxillary First Molar Tipping
The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.
Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)
Study Arms (3)
IPE Group
EXPERIMENTALParticipants in this group will receive treatment with the Invisalign Palatal Expander (IPE). Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.
RME Group
EXPERIMENTALParticipants in this group will receive treatment with an acrylic cap splint Rapid Maxillary Expansion (RME) appliance. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months.
Control Group
NO INTERVENTIONParticipants in this group will not receive orthodontic expansion treatment during the study period and will serve as untreated controls. 3D intraoral and extraoral scans will be obtained at the same time points as treatment groups (end of expansion period equivalent, 3 months, 6 months).
Interventions
A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.
Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.
Eligibility Criteria
You may qualify if:
- Children aged 6-12 years
- Good oral hygiene and adequate patient cooperation
- No previous orthodontic expansion treatment
You may not qualify if:
- Systemic diseases affecting growth, bone metabolism, or craniofacial development
- Craniofacial syndromes or congenital anomalies
- Severe behavioral or cooperation problems
- Previous orthodontic or orthopedic maxillary expansion
- Patients undergoing medications that affect bone metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34093, Turkey (Türkiye)
Related Publications (2)
Bruni A, Ferrillo M, Gallo V, Parrini S, Garino F, Castroflorio T, Deregibus A. Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):203-214. doi: 10.1016/j.ajodo.2024.04.006. Epub 2024 Jul 26.
PMID: 39066746RESULTTurker G, Coban G, Bayraktar AU, Kurt G, Kilic E, Alkan A. Three-dimensional palatal morphology and upper arch changes following nonsurgical and surgical maxillary expansion in adults. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Oct;134(4):425-431. doi: 10.1016/j.oooo.2022.02.013. Epub 2022 Mar 3.
PMID: 35490136RESULT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Phd Student
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 4, 2025
Study Start
November 20, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 4, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be available beginning 6 months after publication of the study results, for a period of 5 years.
- Access Criteria
- De-identified individual participant data (IPD), including intraoral and extraoral 3D scans, radiographs along with the study protocol, statistical analysis plan, and analytic code, will be available to qualified researchers. Access will be granted upon reasonable request, reviewed by the principal investigator. Researchers must submit a proposal and sign a data use agreement to ensure confidentiality and appropriate use of the data. Data will be shared through a secure repository after publication of the primary results.
De-identified individual participant data (IPD) from this study, including intraoral and extraoral 3D scans, radiographs will be made available to other researchers upon reasonable request. All data will be anonymized to protect patient confidentiality. Access requests will be reviewed by the principal investigator, and researchers will be required to sign a data use agreement to ensure appropriate and secure use of the data.