Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
3 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Naser City
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Cairo, Naser City, Egypten, 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-post: abdulmaliktaw@gmail.com
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Kontakt:
- Akram Alqadami, Ph.D. Holder
- Telefonnummer: +966561010654
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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.
Andra namn:
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Aktiv 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.
Andra namn:
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Static Occlusal Force Distribution and Symmetry
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Pain and Discomfort
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
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Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
3 september 2026
Först inskickad som uppfyllde QC-kriterierna
3 september 2026
Första postat (Faktisk)
9 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1596/588
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Individual participant data will not be made publicly available to protect participant privacy and confidentiality.
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