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临床试验/CTRI/2025/07/091453
CTRI/2025/07/091453尚未招募4 期

Comparative evaluation of skeletal and dentoalveolar changes using two miniscrews versus four miniscrews assisted rapid palatal expansion in young adult patients with a transverse skeletal discrepancy: a cone-beam computed tomography study

Anisha Rajan C M1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1)To analyse skeletal and dental effects following two mini screws assisted rapid palatal expansion

研究概览

简要总结

Transverse maxillary deficiency is considered a common problem,  affecting 7.9% of adolescents and nearly 10% of adults. Rapid palatal expansion (RPE) has been widely used in the field of orthodontics since the mid-1960s for increasing the transverse dimensions of the maxilla in growing patients.Rapid palatal expansion enables the separation of the mid palatal suture, which is followed by skeletal orthopaedic expansion.Conventional tooth-anchored RME  could cause dentoalveolar tipping, less skeletal movement, and a lack of long-term stability. This tipping is usually accompanied by some extrusion.These dentoalveolar changes can contribute to vertical changes.

However, the fused, mature mid palatal suture and adjacent articulations limit the desired results for nongrowing patients using conventional RME.To reduce possible unwanted side effects and limitations of conventional RME, Mini-implant assisted rapid palatal expansion appliance (MARPE) was designed to increase the maxillary width in nongrowing patients using mini-implants placed in the cortical bone of the palate and nasal floor (NF).

MARPE could produce more favourable orthopaedic and less dentoalveolar side effects as compared with conventional tooth-borne RME.

There is scarcity of evidence in literature to compare two screws MARPE appliance and four screws MARPE appliance regarding skeletal and dentoalveolar effects.  Four mini screws have more skeletal anchorage than two mini screws mini-implants due to increased number of implants and increase in amount of surface area. This study is done to compare the differences in skeletal and dentoalveolar changes between two screws mini-implant and four screws mini-implant

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Subjects in the age group 15-30 years of either gender indicated for maxillary expansion.
  • Subjects with healthy periodontal tissues.
  • Subjects with no prior history of orthodontic treatment / orthognathic surgery.

排除标准

  • Pharyngeal pathologies
  • Nasal obstruction, snoring
  • Obstructive sleep apnoea
  • Adenoidectomy, tonsillectomy
  • Patient allergic to Local anesthetic.

结局指标

主要结局

1)To analyse skeletal and dental effects following two mini screws assisted rapid palatal expansion

时间窗: baseline, 5 weeks

2)To analyse skeletal and dental effects following four mini screws assisted rapid palatal expansion

时间窗: baseline, 5 weeks

次要结局

  • To compare the skeletal effects following two mini screws versus four mini screws assisted rapid palatal expansion(To compare the dentoalveolar effects following two mini screws versus four mini screws assisted rapid palatal expansion)

研究者

发起方
Anisha Rajan C M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anisha Rajan C M

Governmnet Dental College and hospital, Mumbai

研究点 (1)

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