Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
3 de septiembre de 2026 actualizado por: Abdulmalek Tawfik Saad, Al-Azhar University
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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
16
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Naser City
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Cairo, Naser City, Egipto, 11751
- Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
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Contacto:
- Abdulmalek Alqadami, M.Sc. Candidate
- Número de teléfono: +201555441176 +201553118136
- Correo electrónico: abdulmaliktaw@gmail.com
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Contacto:
- Akram Alqadami, Ph.D. Holder
- Número de teléfono: +966561010654
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group I: Adolescents
Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).
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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.
Otros nombres:
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.
Otros nombres:
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Comparador activo: Group II: Young Adults
Young adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).
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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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Static Occlusal Force Distribution and Symmetry
Periodo de tiempo: Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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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.
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Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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Dynamic Occlusal Parameters (Occlusion and Disclusion Times)
Periodo de tiempo: Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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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).
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Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative Pain and Discomfort
Periodo de tiempo: Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
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Self-reported pain intensity evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
3 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Publicado por primera vez (Actual)
9 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1596/588
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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