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Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization

NCT07534072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-16

No results posted yet for this study

Summary

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

DEVICE

skeletally anchored Modified Leaf Expander

Intervention Elastic separators were placed mesial and distal to the maxillary first molars bilaterally for 3 days to create space for band placement (19). Appropriate bands were selected and fitted to the molars. An alginate impression was taken with the bands in place, then the bands were removed and repositioned in the impression. The impression was poured in stone to fabricate the working model. Fabrication of the Modified Palatally Anchored Expander Appliance The positions of the screws for skeletal anchorage were determined on the model within a safe square on the anterior palatal area. Four lines were drawn (9): * The first line, 8 mm distal to the incisive papilla, marked the anterior boundary. * The second line, parallel to the first, passed through the distal surfaces of the second premolars to mark the posterior boundary. * Two additional lines, each 8 mm lateral to the median palatal raphe, were drawn perpendicular to the first two lines. The four-point support expander was

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Nouran Eissa, Ass. lect · Tanta University

  • Mohamed Elbialy, Lecturer · El mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-07-14
Completion
2025-08-12

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534072 on ClinicalTrials.gov