Three-dimensional CBCT Analysis of Root Volume Changes Following Tooth-bone and Bone-borne Maxillary Expansion: A Pilot Study.

NCT06912568 | Completed

• 1 other identifier: URomLS_5951a
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

External root resorption (ERR) is an undesired side effect observed after rapid maxillary expansion (RME). This study aimed to investigate changes in the root volume of maxillary permanent first molars after RME using tooth-borne and bone-borne devices with cone-beam computed tomography (CBCT) software analysis. The study included 21 patients (mean age 11.8 years ±0.79 years) with skeletal transverse maxillary deficiency, randomly allocated into three groups according to the type of expansion device: tooth-borne Hyrax (TB), bone-borne 4-miniscrew (BB4) and bone-borne 2-miniscrew (BB2). The same expansion screw and activation protocol were applied in all groups. A CBCT was carried out before treatment (T0) and after treatment at a 6-month follow-up (T1). The volumetric assessment of maxillary permanent first molars was performed using digital software, evaluating the mean root volume changes (mm3 and %) between T0 and T1 in each group (TB, BB4, BB2). The Wilcoxon test was used for intra-group comparisons and the Kruskal-Wallis test was used for inter-group comparisons. Significance was set at P≤0.05.

Conditions

Root Resorption; Orthodontic Appliance; CBCT Segmentation

Keywords

tooth-borne RME; bone-borne RME; external root resorption; maxillary expansion; CBCT; miniscrews

Outcome Measures

Primary Outcomes (1)

• root volume changes of maxillary permanent first molars following the active expansion phase.

  up to 14 months

Study Arms (3)

4 miniscrews Bone-borne expansion group

EXPERIMENTAL

Device: Miniscrew insertion; Device: Expander; Radiation: CBCT

2 miniscrews bone-borne group

EXPERIMENTAL

Device: Miniscrew insertion; Device: Expander; Radiation: CBCT

tooth-borne expander

EXPERIMENTAL

Device: Expander; Radiation: CBCT

Interventions

Miniscrew insertion DEVICE

four or two miniscrews insertions using computer-guided minimally-invasive and flapless approach

2 miniscrews bone-borne group; 4 miniscrews Bone-borne expansion group

Expander DEVICE

In the TB group, the tooth-borne hyrax appliance was designed with bands on the maxillary first molars; in the BB4 group, the bone-borne expander was supported by 4 miniscrews inserted both in paramedian and parapalatal position of the palatal vault; in the BB2 group, the bone-borne expander was supported by 2 miniscrews inserted in the paramedian region of the palate. The same type of expansion screw and expansion protocol were used in all groups. Specifically, a 10mm hyrax click screw (Dentaurum, Bologna, Italy) was activated by 4 quarter-turns on the first day and by 3 quarter-turns per day during the active phase of treatment (0.20mm per turn, 0.6mm daily) until an 8mm screw opening was achieved.

2 miniscrews bone-borne group; 4 miniscrews Bone-borne expansion group; tooth-borne expander

CBCT RADIATION

All patients underwent CBCT examinations before the application of the RME device (T0) and post-treatment, after the 6-month retention period (T1). The exposure settings were as follows: 10 mA, 90 kV, total scanning time of 15.0 seconds, effective radiation time of 4.0 seconds, voxel size of 0.2 mm, scanning area of 14 x 16.5 cm, and an effective radiation dose of approximately 524 mGy/cm2. The CBCT images analyzed in this study were not acquired specifically for this research but were part of an ongoing prospective randomized clinical trial aimed at evaluating the skeletal and dentoalveolar effects of three different orthodontic devices. The imaging protocol was established in accordance with ethical guidelines and was approved by the relevant institutional review board.

2 miniscrews bone-borne group; 4 miniscrews Bone-borne expansion group; tooth-borne expander

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 previous orthodontic treatment,
• good oral hygiene,
• completion of apexification of permanent first molars,
• availability of adequate pre-treatment and post-retention CBCT records

You may not qualify if:

• any systemic syndrome
• acute oral infections

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery

Rome, Rome, 00161, Italy

Location

MeSH Terms

Conditions

Root Resorption

Interventions

Tissue Expansion Devices

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• 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 4, 2025
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)