Maxillary Transverse DeficiencyNCT07810465
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
A study testing Piezocision-Assisted Rapid Maxillary Expansion and T-Scan Quantitative Digital Occlusal Force Analysis in people with Maxillary Transverse Deficiency and Rapid Maxillary Expansion, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- Maxillary Transverse Deficiency, Rapid Maxillary Expansion, Posterior Crossbite
- What is being tested?
- Piezocision-Assisted Rapid Maxillary Expansion and T-Scan Quantitative Digital Occlusal Force Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1 - Patients with transverse maxillary deficiency. 2. Age range 14-22 years 3. Permanent dentition stage. 4. Good general and oral health.
Who cannot join
- Craniofacial anomalies or syndromes.
- History of orthognathic surgery.
- Periodontal disease or significant bone loss.
- Systemic diseases affecting bone metabolism.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
Cairo, Naser City, 11751
Abdulmalek Alqadami, M.Sc. Candidate, +201553118136 ext. +201555441176, abdulmaliktaw@gmail.com
Akram Alqadami, Ph.D. Holder, +966561010654
About this study
Official title: Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Adolescent Versus Young Adult Orthodontic Patients: A Prospective Clinical Study.
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.
Read the detailed description
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.
- Being tested
- Piezocision-Assisted Rapid Maxillary Expansion, T-Scan Quantitative Digital Occlusal Force Analysis
- Keywords
- Piezocision, Rapid Maxillary Expansion, Occlusal Force Distribution, T-Scan, Orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezocision-Assisted Rapid Maxillary ExpansionProcedure or surgery
Also called Piezocision-Assisted RME, Piezoelectric Corticotomy, Piezo-Assisted Maxillary Expansion, Piezocision-Assisted Rapid Palatal Expansion
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.
T-Scan Quantitative Digital Occlusal Force AnalysisDiagnostic test
Also called T-Scan Digital Occlusal System, Tekscan Occlusal Force Analysis, Digital Occlusal Analysis, Digital Occlusal Force Measurement
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Adolescents | Experimental | Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME). Receives: 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). Receives: Procedure: Piezocision-Assisted Rapid Maxillary Expansion; Diagnostic Test: T-Scan Quantitative Digital Occlusal Force Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Transverse DeficiencyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulmalek Tawfik Saad, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810465
- Sponsor's protocol ID
- 1596/588
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Adolescent Versus Young Adult Orthodontic Patients: A Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT07810465
- Acronym / sponsor ID
- 1596/588
- Keywords
- Piezocision, Rapid Maxillary Expansion, Occlusal Force Distribution, T-Scan, Orthodontics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Adolescents | Experimental | Procedure: Piezocision-Assisted Rapid Maxillary Expansion, Diagnostic Test: T-Scan Quantitative Digital Occlusal Force AnalysisAdolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME). |
| Group II: Young Adults | Active comparator | Procedure: Piezocision-Assisted Rapid Maxillary Expansion, Diagnostic Test: T-Scan Quantitative Digital Occlusal Force AnalysisYoung adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME). |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1 - Patients with transverse maxillary deficiency. 2. Age range 14-22 years 3. Permanent dentition stage. 4. Good general and oral health.
Key exclusion criteria (5 listed)
- Craniofacial anomalies or syndromes.
- History of orthognathic surgery.
- Periodontal disease or significant bone loss.
- Systemic diseases affecting bone metabolism.
- Previous orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezocision-Assisted Rapid Maxillary ExpansionAlso: Piezocision-Assisted RME, Piezoelectric Corticotomy, Piezo-Assisted Maxillary Expansion, Piezocision-Assisted Rapid Palatal ExpansionUnder 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. | Procedure or surgery | Group I: Adolescents, Group II: Young Adults |
| T-Scan Quantitative Digital Occlusal Force AnalysisAlso: T-Scan Digital Occlusal System, Tekscan Occlusal Force Analysis, Digital Occlusal Analysis, Digital Occlusal Force MeasurementQuantitative 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. | Diagnostic test | Group I: Adolescents, Group II: Young Adults |
Primary outcome
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.
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).
1 secondary outcome
Postoperative Pain and Discomfort
Time frame: Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
Related trials for Maxillary Transverse Deficiency
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Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
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Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
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Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
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Posterior Crossbite, Maxilla; Hypoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision-Assisted Rapid Maxillary Expansion and T-Scan Quantitative Digital Occlusal Force Analysis in people with Maxillary Transverse Deficiency and Rapid Maxillary Expansion, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Occlusal Force Distribution and Symmetry (time frame: Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.