Prospective Randomized Controlled Study Comparing Dentoalveolar, Skeletal, Periodontal and Nasal/Airway Effects of a Two-miniscrew Bone-borne Expander, a Four-miniscrew Bone-borne Expander, and a Conventional Tooth-borne Hyrax Expander in Adolescents.
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- University of Roma La Sapienza
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1)
概览
简要总结
Rapid maxillary expansion (RME) is used to correct transverse deficiencies of the maxilla. This randomized controlled trial compares three RME devices in adolescents (age 10-15) with at least 8 mm maxillary transverse deficiency: (1) bone-borne expander supported by two palatal miniscrews, (2) bone-borne expander supported by four palatal miniscrews, and (3) conventional tooth-borne Hyrax expander. Devices were placed using static computer-guided miniscrew insertion (where applicable). All participants received the same activation protocol to reach 8 mm expansion. Cone-beam CT scans were obtained pre-treatment (T0) and at 6 months post-treatment (T1). The trial assesses skeletal, dentoalveolar, periodontal, and nasal/airway outcomes. Enrollment: 36 subjects. Study sites: Sapienza University of Rome.
详细描述
This is a prospective, randomized, parallel-group clinical trial performed at the Department of Oral and Maxillofacial Sciences, Sapienza University of Rome (Nov 2021 - Sep 2024). Inclusion criteria included age under 16 years, late mixed or permanent dentition, and maxillary transverse deficiency ≥ 8 mm. Exclusion: poor oral hygiene; previous orthodontic treatment; craniofacial syndromes; cleft lip/palate; genetic/congenital diseases. After consent, eligible participants (N=36) were randomized (1:1:1) to: Group A - two-miniscrew bone-borne expander (paramedian screws near 1st-2nd premolar region); Group B - four-miniscrew bone-borne expander (two paramedian + two parapalatine); Group C - Hyrax tooth-borne expander banded to upper first molars. Miniscrews (Benefit system; PSM Medical Solutions) were placed using a CAD-CAM surgical guide planned from CBCT and digital models (Easy Driver). Activation: Hyrax click 10 mm screw; four quarter-turns at insertion then three quarter-turns/day for 12 days (0.20 mm/turn; ~0.6 mm/day) until 8 mm achieved. CBCT scan acquisition: Scanora 3Dx (Soredex). Measurements performed on Simplant v17 on defined landmarks (MaxBas, MaxAlv, MaxAlvPre, Ns, ZigMax, IntermCo, IntermoAp, molar angles, periodontal bone thickness measures, nasopalatine foramen width). Primary outcome: change in maxillary basal width (MaxBas) T0 to T1 measured on CBCT.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 to 15 years (under 16 at enrollment).
- •Late mixed or permanent dentition.
- •Maxillary transverse deficiency ≥ 8 mm (unilateral or bilateral).
- •Parent/guardian able to provide written informed consent; participant assent where applicable.
排除标准
- •Poor oral hygiene.
- •Prior orthodontic treatment.
- •Craniofacial syndromes.
- •Cleft lip and/or palate.
- •Genetic or congenital diseases likely to affect craniofacial growth or bone quality.
- •Inability/unwillingness to attend scheduled follow-up visits.
研究组 & 干预措施
Arm 1 (Group A) - Two-miniscrew bone-borne expander
one-borne rapid maxillary expander anchored on two palatal miniscrews inserted in paramedian palatal vault (near first-second premolar area). Miniscrews: self-tapping titanium (Benefit system; PSM Medical Solutions). Placement planned via CBCT-guided CAD/CAM surgical guide (Easy Driver). Activation protocol: Hyrax click 10 mm screw: 4 quarter-turns at placement then 3 quarter-turns/day for 12 days (0.20 mm/turn) until ~8 mm expansion.
干预措施: Miniscrew supported expander application (Device)
Arm 2 (Group B) - Four-miniscrew bone-borne expander
Bone-borne rapid maxillary expander anchored on four palatal miniscrews (two paramedian + two parapalatine). Same guided insertion workflow and activation protocol as Group A.
干预措施: 4 miniscrews supported rapid maxillary expansion application (Device)
Arm 3 (Group C) - Conventional tooth-borne Hyrax expander
Tooth-borne Hyrax expander banded on upper first permanent molars (conventional Hyrax). Same activation protocol as Groups A/B.
干预措施: Conventional tooth-borne Hyrax expander (comparator) (Device)
结局指标
主要结局
Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1)
时间窗: at 6 months
Measurement method: CBCT (Simplant software) distance between alveolar/basal points (points 5-6 as per Podesser/Garib protocol).
次要结局
未报告次要终点
研究者
Michele Cassetta
Professor, DDS, PhD
University of Roma La Sapienza