Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups

NCT07810465 | Not Yet Recruiting

• 1 other identifier: 1596/588
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective clinical study is to evaluate and compare the changes in occlusal force distribution using a quantitative digital occlusal analysis system following piezocision-assisted rapid maxillary expansion (RME) in adolescent versus young adult orthodontic patients. The study hypothesis is that piezocision-assisted RME will result in significant changes in occlusal force distribution and that these outcomes may differ between age groups over a 3-month follow-up period.

Conditions

Maxillary Transverse Deficiency; Rapid Maxillary Expansion; Posterior Crossbite

Keywords

Piezocision; Rapid Maxillary Expansion; Occlusal Force Distribution; T-Scan; Orthodontics

Outcome Measures

Primary Outcomes (2)

• Static Occlusal Force Distribution and Symmetry

  Percentage of occlusal force distribution between anterior/posterior segments and percentage of force symmetry between right and left sides measured at Maximum Intercuspation (MIC) using T-Scan III.

  Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).

• Dynamic Occlusal Parameters (Occlusion and Disclusion Times)

  Occlusion Time (OT in seconds, measured from initial tooth contact to Maximum Intercuspation \[MIC\]) and Disclusion Time (DT in seconds, measured from MIC during lateral and protrusive excursive movements until all posterior teeth completely disclude).

  Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).

Secondary Outcomes (1)

• Postoperative Pain and Discomfort

  Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).

Study Arms (2)

Group I: Adolescents

EXPERIMENTAL

Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

Procedure: Piezocision-Assisted Rapid Maxillary Expansion; Diagnostic Test: T-Scan Quantitative Digital Occlusal Force Analysis

Group II: Young Adults

ACTIVE COMPARATOR

Young adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

Procedure: Piezocision-Assisted Rapid Maxillary Expansion; Diagnostic Test: T-Scan Quantitative Digital Occlusal Force Analysis

Interventions

Piezocision-Assisted Rapid Maxillary Expansion PROCEDURE

Under local anesthesia using Articaine with 1:100,000 Epinephrine, selective vertical micro-incisions are made interproximally through the attached gingiva to the maximum extent possible using a 15c scalpel blade via a flapless technique, extending through the periosteum to reach the alveolar bone. Corticotomy cuts are performed using a piezoelectric surgical device with a BS1 Slim II tip to a depth of 3 mm into cortical bone, initiated 2 mm apical to alveolar crest and safely positioned between adjacent tooth roots to avoid iatrogenic injury. Immediately following surgery, activation of a bonded tooth-borne Hyrax expander commences at a rate of one activation (quarter turn) twice daily (0.5 mm/day) for 11 days, followed by a 3-month passive retention phase for suture remodeling.

Also known as: Piezocision-Assisted RME, Piezoelectric Corticotomy, Piezo-Assisted Maxillary Expansion, Piezocision-Assisted Rapid Palatal Expansion

Group I: Adolescents; Group II: Young Adults

T-Scan Quantitative Digital Occlusal Force Analysis DIAGNOSTIC_TEST

Quantitative digital measurement of occlusal force parameters using the T-Scan III system (Tekscan, Inc., Norwood, MA, USA) with HD sensors. Static parameters assessed at Maximum Intercuspation (MIC) include: (1) percentage of force distribution between anterior and posterior teeth, and (2) percentage of force symmetry between right and left arch sides. Dynamic parameters assessed include: (1) Occlusion Time (OT) measured from initial tooth contact to MIC, and (2) Disclusion Time (DT) recorded during right, left, and protrusive excursive movements.

Also known as: T-Scan Digital Occlusal System, Tekscan Occlusal Force Analysis, Digital Occlusal Analysis, Digital Occlusal Force Measurement

Group I: Adolescents; Group II: Young Adults

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with transverse maxillary deficiency. 2. Age range 14-22 years 3. Permanent dentition stage. 4. Good general and oral health.

You may not qualify if:

• Craniofacial anomalies or syndromes.
• History of orthognathic surgery.
• Periodontal disease or significant bone loss.
• Systemic diseases affecting bone metabolism.
• Previous orthodontic treatment.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University

Cairo, Naser City, 11751, Egypt

Location

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: Master's Student in Orthodontic department

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)