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临床试验/NCT07810465
NCT07810465尚未招募不适用

Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Adolescent Versus Young Adult Orthodontic Patients: A Prospective Clinical Study.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
1
主要终点
Static Occlusal Force Distribution and Symmetry

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 1 - Patients with transverse maxillary deficiency.
  • Age range 14-22 years
  • Permanent dentition stage.
  • Good general and oral health.

排除标准

  • Craniofacial anomalies or syndromes.
  • History of orthognathic surgery.
  • Periodontal disease or significant bone loss.
  • Systemic diseases affecting bone metabolism.
  • Previous orthodontic treatment.

研究组 & 干预措施

Group I: Adolescents

Experimental

Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

干预措施: Piezocision-Assisted Rapid Maxillary Expansion (Procedure)

Group I: Adolescents

Experimental

Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

干预措施: T-Scan Quantitative Digital Occlusal Force Analysis (Diagnostic Test)

Group II: Young Adults

Active Comparator

Young adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

干预措施: Piezocision-Assisted Rapid Maxillary Expansion (Procedure)

Group II: Young Adults

Active Comparator

Young adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).

干预措施: T-Scan Quantitative Digital Occlusal Force Analysis (Diagnostic Test)

结局指标

主要结局

Static Occlusal Force Distribution and Symmetry

时间窗: 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)

时间窗: 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).

次要结局

  • Postoperative Pain and Discomfort(Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulmalek Tawfik Saad

Master's Student in Orthodontic department

Al-Azhar University

研究点 (1)

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