Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
3 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Naser City
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Cairo, Naser City, Egypte, 11751
- Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
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Contact:
- Abdulmalek Alqadami, M.Sc. Candidate
- Numéro de téléphone: +201555441176 +201553118136
- E-mail: abdulmaliktaw@gmail.com
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Contact:
- Akram Alqadami, Ph.D. Holder
- Numéro de téléphone: +966561010654
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Static Occlusal Force Distribution and Symmetry
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative Pain and Discomfort
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 juin 2028
Dates d'inscription aux études
Première soumission
3 septembre 2026
Première soumission répondant aux critères de contrôle qualité
3 septembre 2026
Première publication (Réel)
9 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1596/588
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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