Leaf Expander vs Hyrax for Molar Distalization
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered a randomized controlled trial comparing skeletally anchored modified Leaf Expander versus conventional Hyrax Expander for maxillary molar distalization in 30 patients aged 15-18 years. The three-year study will evaluate skeletal, dental, and arch dimensional changes using lateral cephalometric radiographs and digital dental models.
What changed
This registry entry documents a new randomized controlled trial registered on ClinicalTrials.gov comparing two orthodontic expansion devices for maxillary molar distalization. The study plans to enroll 30 adolescent patients split into two groups receiving either the modified Leaf Expander or the modified Hyrax Expander. For healthcare providers and patients, this represents informational content about an upcoming clinical study investigating orthodontic treatment alternatives. The registry entry provides standard trial metadata including methodology, inclusion criteria, and anticipated completion date but imposes no compliance obligations.
Implications for affected parties are limited to informational purposes. Orthodontic practices and dental researchers may reference this trial for background on current orthodontic research directions. Patients meeting the age and condition criteria (15-18 years, requiring maxillary molar distalization) may consider enrollment if eligible. No regulatory reporting or compliance actions are required from this database entry.
What to do next
- Monitor ClinicalTrials.gov for enrollment updates
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization
N/A NCT07534072 Kind: NA Apr 16, 2026
Abstract
Background:
Distalization in orthodontics is one of conservative treatment modalities that result in gaining space especially in dental orthodontic cases of class ΙΙ molar relationship.
Aim:
This study aimed to compare the distalization effects of the skeletally anchored modified Leaf Expander versus the skeletally anchored modified conventional Hyrax Expander.
Patients and Methods:
Thirty patients (15-18 years) requiring maxillary molar distalization were randomly allocated into two groups (n = 15 each). Group 1 received the modified skeletally anchored self-activated Leaf Expander, and Group 2 received the modified skeletally anchored conventional Hyrax Expander. Pre- and post-distalization lateral cephalometric radiographs and digital dental models were analyzed for skeletal, dental, and arch dimensional changes. Treatment duration and adverse events were also recorded. Statistical analysis included paired t-tests and independent t-tests, with Bonferroni correction (α = 0.0045) applied for multiple comparisons. Effect sizes (Cohen's d) were calculated to assess clinical relevance.
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Conditions: Orthodontic Patients
Interventions: skeletally anchored Modified Leaf Expander
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