Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07810465

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Maxillary Transverse Deficiency Posterior Crossbite Rapid Maxillary Expansion

Age range

14 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Naser City, 11751, Egypt

Location contact

Abdulmalek Alqadami, M.Sc. Candidate

CONTACT

[email protected]

+201553118136 ext. +201555441176

Akram Alqadami, Ph.D. Holder

CONTACT

+966561010654

About this study

This prospective clinical study evaluates the changes in occlusal force distribution in patients with maxillary transverse deficiency undergoing piezocision-assisted rapid maxillary expansion (RME).

Participants aged 14-22 years with permanent dentition requiring rapid maxillary expansion are allocated into two age-based study groups:

Group I (Adolescents): Patients aged 14-16 years. Group II (Young Adults): Patients aged 18-22 years. All participants undergo piezocision-assisted RME. Under local anesthesia, selective vertical micro-incisions are made interproximally on the buccal alveolar bone distal to the canines, first premolars, and second premolars. Corticotomy cuts to a depth of 3 mm into cortical bone are performed using a piezoelectric surgical device. A bonded tooth-borne Hyrax expander is then cemented and activated two quarters per day (0.5 mm of expansion per day) for 11 days. The expander is maintained as a passive retainer for 3 months to allow stabilization and midpalatal suture remodeling. Primary outcomes evaluate percentage changes in occlusal force distribution at maximum intercuspation across dental arch segments (Anterior vs. Posterior and Right vs. Left), as well as occlusion time and disclusion time during excursive movements, using quantitative digital occlusal force analysis(T-Scan III, Tekscan Inc., Norwood, MA, USA)). Secondary outcomes assess patient-reported pain and discomfort levels at defined time intervals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Piezocision-Assisted RME, Piezoelectric Corticotomy, Piezo-Assisted Maxillary Expansion, Piezocision-Assisted Rapid Palatal Expansion

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.

Other names: T-Scan Digital Occlusal System, Tekscan Occlusal Force Analysis, Digital Occlusal Analysis, Digital Occlusal Force Measurement

Primary outcomes

  1. Static Occlusal Force Distribution and Symmetry

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

    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.

  2. Dynamic Occlusal Parameters (Occlusion and Disclusion Times)

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

    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).

Secondary outcomes

  1. Postoperative Pain and Discomfort

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

    Self-reported pain intensity evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Adolescent Versus Young Adult Orthodontic Patients: A Prospective Clinical Study.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.