Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
3. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
16
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Naser City
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Cairo, Naser City, Ägypten, 11751
- Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
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Kontakt:
- Abdulmalek Alqadami, M.Sc. Candidate
- Telefonnummer: +201555441176 +201553118136
- E-Mail: abdulmaliktaw@gmail.com
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Kontakt:
- Akram Alqadami, Ph.D. Holder
- Telefonnummer: +966561010654
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
Andere Namen:
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.
Andere Namen:
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Aktiver Komparator: 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.
Andere Namen:
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Static Occlusal Force Distribution and Symmetry
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Postoperative Pain and Discomfort
Zeitfenster: 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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Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2027
Studienabschluss (Geschätzt)
1. Juni 2028
Studienanmeldedaten
Zuerst eingereicht
3. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. September 2026
Zuerst gepostet (Tatsächlich)
9. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 1596/588
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Beschreibung des IPD-Plans
Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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