Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-22
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Craniofacial anomalies or syndromes.
History of orthognathic surgery.
Periodontal disease or significant bone loss.
Systemic diseases affecting bone metabolism.
Trial design
Design model
Parallel
Treatments tested in this trial
Piezocision-Assisted Rapid Maxillary Expansion
Procedure/SurgeryUnder 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.
T-Scan Quantitative Digital Occlusal Force Analysis
Diagnostic testQuantitative 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Group I: AdolescentsExperimental treatment 2 interventions
Group B: Group II: Young AdultsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).2
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).
Time frame
Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).Secondary outcomes
1
Postoperative Pain and Discomfort
Self-reported pain intensity evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame
Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).Sponsors and contacts
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Source ClinicalTrials.gov
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