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临床试验/NCT07845227
NCT07845227已完成不适用

Effect of a Palatal Guide Wire on Maxillary Canine Displacement During Miniscrew-Supported Distalization: A Split-Mouth Randomized Controlled Trial

Atlas University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Cumulative distopalatal rotation of the maxillary canine

研究概览

简要总结

When crowded or protruded teeth are treated by removing an upper premolar on each side, the canine (eye tooth) is first moved backward into the space. As it moves, the tooth tends to rotate and tip out of position, and this rotation is one of the hardest movements to correct and most likely to come back later. This study tested a simple addition to the usual treatment: a small passive wire attached to the inner (palate) side of the canine and connected to the back tooth, meant to guide the canine and keep it from rotating, without adding any extra force.

Sixteen adolescents who needed an upper premolar removed on both sides took part. Because each person has two sides, every patient received both approaches at once: on one randomly chosen side the guide wire was added, and the other side was treated the same way but without it, serving as that patient's own comparison. This split-mouth design lets each patient act as their own control.

The canine was moved backward on both sides using the same light spring and a small bone screw for anchorage. The researchers took dental scans at the start and after one, two, and three months and measured how far each canine moved, how much it rotated and tipped, and whether the back tooth drifted forward. The goal was to find out whether the guide wire reduces unwanted rotation and tipping and affects how quickly the canine moves, without weakening the anchorage.

详细描述

This was a prospective, single-center, split-mouth randomized controlled trial conducted in the Department of Orthodontics, Faculty of Dentistry, Ondokuz Mayıs University. Sixteen patients (12 female, 4 male; mean age 16.6 ± 1.7 years) with Angle Class II division 1 or 2 malocclusion requiring bilateral maxillary first premolar extraction with maximum anchorage were enrolled.

In each patient, the side to receive the guide wire was randomly allocated, balanced so that the guide wire was placed on the right side in 8 patients and on the left in 8. Both canines were distalized with a 150-g nickel-titanium closed coil spring extended from an interradicular miniscrew to a U-shaped power arm seated in the vertical slot of the canine bracket. On the experimental side only, a passive 0.020-inch round stainless steel wire was engaged between a bracket bonded to the palatal surface of the canine and the first molar band sheath; this wire was never activated and added no force to the system.

Alginate impressions were taken at the start of distalization (T0) and after 1 (T1), 2 (T2), and 3 (T3) months. Casts were scanned and superimposed on the medial and lateral limits of the third palatal ruga and the medial limit of the second. Distopalatal rotation, canine distalization, canine tipping, and first molar anchorage loss were measured and compared between the guide wire and control sides using paired statistics on the within-patient difference.

研究设计

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

盲法说明

The operator was blinded to allocation until the T0 appointment, so the side to receive the guide wire was unknown during the preparatory phase. Blinding could not be maintained thereafter because the palatal attachment is visible both intraorally and on the scanned casts; no party could be masked once the appliance was placed.

入排标准

年龄范围
14 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Angle Class II division 1 or division 2 malocclusion
  • •Indication for maxillary first premolar extraction
  • •Maximum anchorage requirement
  • •Minimal or no maxillary incisor crowding
  • •No previous orthodontic treatment
  • •No congenitally missing or previously extracted maxillary teeth other than third molars
  • •Completed pubertal growth spurt

排除标准

  • •Any systemic disease or regular medication use
  • •Poor oral hygiene or active periodontal disease

研究组 & 干预措施

Guide wire side

Experimental

The maxillary canine on the randomly allocated side was distalized with a 150-g nickel-titanium closed coil spring from an interradicular miniscrew to a power arm in the vertical slot of the canine bracket, with a passive palatal guide wire engaged between a bracket on the palatal surface of the canine and the first molar band sheath.

干预措施: Palatal guide wire (Device)

Guide wire side

Experimental

The maxillary canine on the randomly allocated side was distalized with a 150-g nickel-titanium closed coil spring from an interradicular miniscrew to a power arm in the vertical slot of the canine bracket, with a passive palatal guide wire engaged between a bracket on the palatal surface of the canine and the first molar band sheath.

干预措施: Miniscrew-supported canine distalization (Procedure)

Control side

Active Comparator

The contralateral canine was distalized with the identical coil-spring and power-arm system, without a palatal guide wire.

干预措施: Miniscrew-supported canine distalization (Procedure)

结局指标

主要结局

Cumulative distopalatal rotation of the maxillary canine

时间窗: Baseline (T0) and 3 months (T3)

Change from baseline in the angle between the sagittal reference line and a line through the canine cusp tip along the palatal ridge, measured on rugae-superimposed digital models and compared between the guide wire and control sides.

Cumulative canine distalization

时间窗: Baseline (T0) and 3 months (T3)

Change from baseline in the perpendicular distance from the canine cusp tip to the sagittal reference line, compared between the guide wire and control sides.

次要结局

  • Canine tipping(Baseline (T0) and 3 months (T3))
  • First molar anchorage loss(Baseline (T0) and 3 months (T3))
  • Monthly rate of canine distalization and rotation(T0, 1 month (T1), 2 months (T2), and 3 months (T3))

研究者

发起方
Atlas University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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