ChiCTR2600126098 版本V1.0 版本创建时间2026/06/03 16:43:58 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600126098 

最近更新日期：

Date of Last Refreshed on：

 2026-06-03 16:43:20 

注册时间：

Date of Registration：

 2026-06-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

改良式Twin-Block矫治器联合J钩高位牵引与传统Twin-Block矫治器的临床对照研究

Public title：

A Clinical Controlled Study of Modified Twin-Block Appliance Combined with J-Hook High-Pull Traction versus Traditional Twin-Block Appliance

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良式Twin-Block矫治器联合J钩高位牵引的应用与效果分析

Scientific title：

Application and Effect Analysis of Modified Twin-Block Appliance Combined with J-Hook High-Pull Traction

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

宋一鸣 

研究负责人：

郭力嘉 

Applicant：

Yiming Song 

Study leader：

Lijia Guo 

申请注册联系人电话：

Applicant telephone：

 +86 17856656722

研究负责人电话：

Study leader's
telephone：

+86 10 5709 9661

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 sym020403@163.com

研究负责人电子邮件：

Study leader's E-mail：

 orthoest@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市丰台区樊家村路9号

研究负责人通讯地址：

北京市丰台区樊家村路9号院

Applicant address：

No.9 Fanjiacun Road, Fengtai District, Beijing, China

Study leader's address：

No.9 Fanjiacun Road, Fengtai District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

首都医科大学附属北京口腔医院

Applicant's institution：

Beijing Stomatological Hospital , Capital Medical University

研究负责人所在单位：

首都医科大学附属北京口腔医院

Affiliation of the Leader：

Beijing Stomatological Hospital , Capital Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 CMUSH-IRB-KJ-PJ-2026-24

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京口腔医院伦理委员会

Name of the ethic committee：

Institutional Review Board of Beijing Stomatological Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-23 00:00:00

伦理委员会联系人：

夏晓钰

Contact Name of the ethic committee：

Xia Xiaoyu

伦理委员会联系地址：

北京市丰台区樊家村路9号院

Contact Address of the ethic committee：

No.9 Fanjiacun Road, Fengtai District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 57099307

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 18602615270@163.com

研究实施负责（组长）单位：

首都医科大学附属北京口腔医院

Primary sponsor：

Beijing Stomatological Hospital , Capital Medical University

研究实施负责（组长）单位地址：

北京市丰台区樊家村路9号院

Primary sponsor's address：

No.9 Fanjiacun Road, Fengtai District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京口腔医院

具体地址：

北京市丰台区樊家村路9号院

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Address：

No.9 Fanjiacun Road, Fengtai District, Beijing, China

经费或物资来源：

研究生课题

Source(s) of funding：

Postgraduate Research Project

研究疾病：

骨性II类下颌后缩  

Target disease：

Skeletal Class II mandibular retrognathia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

针对于目前临床广泛使用的传统 Twin-Block 矫治器的不足之处，我们对其进行了改良设计，并获得了一项实用新型专利（专利号：ZL 2024 2 1003597.0）。本研究旨在评估改良式 Twin-Block 矫治器联合 J 钩高位牵引对非低角患者垂直向高度的控制效果，建立针对青少年骨性 II 类非低角患者的“矢状-横向-垂直向三维调控”体系，实现从单纯促进下颌发育到三维生长改建协同控制的范式升级，为临床提供可推广的解决方案。  

Objectives of Study：

In response to the shortcomings of the traditionally used Twin-Block appliance in clinical practice, we have developed an improved design and obtained a utility model patent (Patent No.: ZL 2024 2 1003597.0). This study aims to evaluate the effect of the improved Twin-Block appliance combined with high-position J-hook traction on vertical height control in non-low-angle patients, and to establish a "sagittal-transverse-vertical three-dimensional regulation" system for adolescent skeletal Class II non-low-angle patients. This approach aims to upgrade the paradigm from merely promoting mandibular development to coordinated three-dimensional growth remodeling, providing a practical solution for clinical application.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 2020年1月-2026年3月在首都医科大学附属北京口腔医院王府井院区正畸科已完成治疗的患者； 2. 治疗前年龄8-13岁，替牙期或恒牙列早期患者，性别不限； 3. 治疗前上颌发育基本正常，下颌后缩的骨性II类患者（78° < SNA < 85.8°，SNB < 78°，ANB > 4°）； 4. 治疗前非低角； 5. 无明显颌面部畸形； 6. 本次治疗前未接受过正畸治疗。

Inclusion criteria

1.Patients who completed treatment in the Department of Orthodontics, Wangfujing Campus, Beijing Stomatological Hospital, Capital Medical University, from January 2020 to March 2026;
2.Aged 8–13 years at pretreatment, in the mixed dentition or early permanent dentition stage, with no gender restriction;
3.Skeletal Class II patients with basically normal maxillary development and mandibular retrognathia at pretreatment (78° < SNA < 85.8°, SNB < 78°, ANB > 4°);
4.Non-low-angle pattern at pretreatment;
5.No obvious maxillofacial deformities;
6.No previous orthodontic treatment before the present treatment;

排除标准：

1.伴有严重全身性或精神疾病；
2.治疗前颌骨外伤史、手术史；
3.先天缺牙；
4.颞下颌关节病；
5.严重牙周病；
6.治疗前后相关影像学资料（头侧片、CBCT）不完整或不清晰；
7.智力障碍者；

Exclusion criteria：

1.With severe systemic or mental diseases;
2.History of maxillofacial trauma or surgery before treatment;
3.Congenital tooth agenesis;
4.Temporomandibular joint disorders (TMD);
5.Severe periodontal disease;
6.Incomplete or unclear relevant imaging data (lateral cephalograms, CBCT) before and after treatment;
7.Patients with intellectual disability;

研究实施时间：

Study execute time：

从 From 2025-06-27 00:00:00至 To 2027-06-27 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

分为试验组（改良Twin-Block+J钩高位牵引）

样本量：

 20

Group：

The patients were divided into the experimental group (modified Twin-Block + J-hook high-pull traction)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

对照组（传统Twin-Block）

样本量：

 20

Group：

control group (conventional Twin-Block).

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属北京口腔医院 

单位级别：

 三级甲等 

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

蝶鞍点- 鼻根点- 下牙槽座角

指标类型：

主要指标

Outcome：

Sella turcica point - Nasion point - Inferior alveolar angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

眶耳平面- 下颌平面角

指标类型：

主要指标

Outcome：

Orbitale-Auriculare Plane - Mandibular Plane Angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

翼上颌裂点- 上牙槽座点距

指标类型：

次要指标

Outcome：

Pterygomaxillary fissure point - distance to upper alveolar ridge point

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

鼻根点- 鼻底点- 颏前点角

指标类型：

次要指标

Outcome：

Nasion point - Subnasale point - Pogonion point angle

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

上中切牙切端至腭平面距

指标类型：

次要指标

Outcome：

Distance from the incisal edge of the maxillary central incisor to the palatal plane

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

髁突长轴长度

指标类型：

次要指标

Outcome：

Condylar long axis length

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下中切牙切端至 NB 线距

指标类型：

次要指标

Outcome：

Distance from the incisal edge of the lower central incisor to the NB line

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

上中切牙长轴- NA 线夹角

指标类型：

次要指标

Outcome：

Maxillary central incisor long axis - NA line angle

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

Z 角

指标类型：

次要指标

Outcome：

Z-angle

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

悬雍垂- 中咽壁距

指标类型：

次要指标

Outcome：

U- MPW(DOP)

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下唇至审美平面距

指标类型：

次要指标

Outcome：

LL- EP

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

翼上颌裂点- 蝶鞍点距

指标类型：

次要指标

Outcome：

Ptm- S

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

前鼻棘点- 颏下点距

指标类型：

次要指标

Outcome：

ANS- Me(FHN)

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

Y轴角

指标类型：

主要指标

Outcome：

Y- axis angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

后鼻棘- 上咽壁距

指标类型：

次要指标

Outcome：

PNS- UPW

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

颏前点至鼻根垂线距

指标类型：

次要指标

Outcome：

Pos- TVL

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

上第一磨牙至腭平面距

指标类型：

次要指标

Outcome：

U6- PP

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

关节后间隙

指标类型：

次要指标

Outcome：

PS（posterior joint space）

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

上牙槽座点- 鼻根点- 下牙槽座角

指标类型：

主要指标

Outcome：

Upper alveolar point - nasion - lower alveolar angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

Wits值

指标类型：

主要指标

Outcome：

Wits appraisal

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

会厌- 下咽壁距

指标类型：

次要指标

Outcome：

V- LPW(DHP)

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下颌平面- 颅底平面角

指标类型：

主要指标

Outcome：

MP- SN

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

髁突点- 颏顶点距

指标类型：

次要指标

Outcome：

Co- Gn

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下中切牙切端至下颌平面距

指标类型：

次要指标

Outcome：

L1- MP

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

上中切牙- 颅底平面角

指标类型：

次要指标

Outcome：

U1- SN

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

关节前间隙

指标类型：

次要指标

Outcome：

AS（anterior joint space）

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

鼻根点- 前鼻棘点距

指标类型：

次要指标

Outcome：

N- ANS(FHN)

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下中切牙- 眶耳平面角

指标类型：

次要指标

Outcome：

FMIA

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

下唇至鼻根垂线距

指标类型：

次要指标

Outcome：

LL- TVL

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

髁突点- 上牙槽座点距

指标类型：

次要指标

Outcome：

Co- A

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

颏前点至眶耳平面垂线距

指标类型：

次要指标

Outcome：

Po- FHN

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

关节上间隙

指标类型：

次要指标

Outcome：

SS（superior joint space）

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

舌背- 舌根后咽壁距

指标类型：

次要指标

Outcome：

TB- TPPW

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

软腭后缘- 软腭后咽壁距

指标类型：

次要指标

Outcome：

SPP- SPPW

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

咬合平面- 眶耳平面角

指标类型：

主要指标

Outcome：

Occlusal Plane - Orbitale Ear Plane Angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

指标中文名：

腭平面- 眶耳平面角

指标类型：

主要指标

Outcome：

Palatal Plane - Orbitomeatal Plane Angle

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

使用Fusion one 软件进行测量，测量两次取平均值。

Measure time point of outcome：

Before and after treatment

Measure method：

Measurements were performed using Fusion One software, and the mean value of two measurements was calculated.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 8 岁 years
最大 Max age 13 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-03 16:43:20