Short-term Stability of Tooth-borne vs Bone-borne Maxillary Expansion: A Parallel Cohort Study

NCT06916299 | Completed

• 1 other identifier: URomLS_5951relapse
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective parallel cohort study aimed to compare the short-term stability of maxillary expansion achieved with tooth-borne (Hyrax) and bone-borne expanders. A total of 36 patients (mean age: 12.3 ± 0.6 years) with transverse maxillary deficiency (≥8 mm) were randomly assigned to two groups: Group A (tooth-borne Hyrax) and Group B (bone-borne expander with four mini-screws). Both groups followed the same activation protocol and underwent an 8-month retention period. After this period, the expansion devices were removed, and relapse was assessed at 12 months post-expansion (T2), corresponding to 4 months after device removal. Digital dental models were analyzed using linear measurements, and statistical analysis was conducted using t-tests (p ≤ 0.05).

Conditions

Orthodontic Appliance; Orthodontic Appliances; Orthodontic Relapse

Keywords

relapse; stability; miniscrews; rapid maxillary expansion

Outcome Measures

Primary Outcomes (1)

• stability

  Variable Description MV Distance between the mesio-vestibular cusps of the upper first permanent molars. MP Distance between the mesio-palatal cusps of the upper first permanent molars. CP Distance between the central pits of the upper first permanent molars. AC Distance between the most vestibular points of the buccal alveolar crest at the level of the dental neck of the upper first permanent molars. VP Distance between the most vestibular points of the mesial vestibular cusps of the upper first permanent molars. ALright Right maxillary arch length, evaluated as the distance between the mesial contact point of the upper right first permanent molar and the contact point between the upper central incisors. ALleft Left maxillary arch length, evaluated as the distance between the mesial contact point of the upper left first permanent molar and the contact point between the upper central incisors. AP The arch perimeter was evaluated as the addition of the length of the segments A(1.4-1.

  up to 14 months

Study Arms (2)

tooth borne expansion

ACTIVE COMPARATOR

Diagnostic Test: dental casts; Device: tooth-borne expander insertion

bone-borne expansion

EXPERIMENTAL

Diagnostic Test: dental casts; Procedure: miniscrew and bone-borne expander insertion

Interventions

dental casts DIAGNOSTIC_TEST

At the end of the planned expansion, an 8-month retention period was expected. At this time, the expansion device was removed, and impressions were taken in both groups (T1). At 12-month follow-up (T2), new impressions were taken in both groups to evaluate, at dental level, the relapse in the short term. Fig 1

bone-borne expansion; tooth borne expansion

tooth-borne expander insertion DEVICE

tooth-borne expander delivery.

tooth borne expansion

miniscrew and bone-borne expander insertion PROCEDURE

Insertion of the paramedian miniscrews in a totally guided procedure, and after was delivered the tooth-borne expander

bone-borne expansion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian children in late mixed dentition or permanent dentition,
• unilateral or bilateral transverse maxillary deficiency of at least 8 mm,
• no patients with skeletal Class III and/or open bite,
• no previous orthodontic treatment,
• good oral hygiene,
• good quality of the plaster models to allow a suitable scanning.

You may not qualify if:

• systemic syndrome involved

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Oral and Maxillofacial Sciences

Rome, Rome, 00161, Italy

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 8, 2025
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)