Comparative Effect of Clear Aligner Mandibular Advancement and Twin Block Appliances in Class II Malocclusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-06-30

Brief Summary

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The goal of this retrospective observational study is to compare the effects of Clear Aligner Mandibular Advancement (MA) and Twin Block (TB) appliances in treating Class II malocclusion, a condition where the lower jaw is underdeveloped. The main questions it aims to answer are:

1. Does mandibular advancement with clear aligners improve jaw and dental alignment as effectively as Twin Block appliances?
2. What are the differences in soft tissue changes, such as chin advancement and lip position, between these two treatments?

Researchers will compare MA and TB appliances to an untreated control group to evaluate their impact on skeletal, dental, and soft tissue outcomes. Participants in the study underwent cephalometric analysis (X-ray measurements) both before and after treatment to assess changes in jaw positioning, overbite, and overjet. The study focuses on how each treatment affects facial aesthetics and dental function.

Participants in the study will:

* Undergo treatment with either clear aligner mandibular advancement or Twin Block appliances.
* Attend follow-up appointments to monitor progress and assess treatment outcomes.

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Detailed Description

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Supplementary information for Study Design It was a retrospective study that collected patients' routine treatment X-rays (before and after treatment) to measure some angular and linear parameters from the X-rays.

Conditions

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CLASS II DIVISION 1 MALOCCLUSION

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MA group

Patients receiving routine care for Class II malocclusion, which may include the use of Clear Aligner with Mandibular Advancement (MA) function appliances

Clear aligner with mandibular function

Intervention Type DEVICE

The MA group underwent stepwise mandibular forward movement with clear aligners (Invisalign, Align Inc, CA, USA) worn for 22 hours/day and replaced every 7 days.

TB group

Patients receiving routine care for Class II malocclusion, which may include the use of Twin Block (TB) appliances

Twin block

Intervention Type DEVICE

The TB group used a single appliance continuously, with appropriate reduction of occlusal surface height by 1 mm when clinically indicated. Both groups had follow-up appointments every 6 weeks.

Interventions

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Twin block

The TB group used a single appliance continuously, with appropriate reduction of occlusal surface height by 1 mm when clinically indicated. Both groups had follow-up appointments every 6 weeks.

Intervention Type DEVICE

Clear aligner with mandibular function

The MA group underwent stepwise mandibular forward movement with clear aligners (Invisalign, Align Inc, CA, USA) worn for 22 hours/day and replaced every 7 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who have completed MA or TB treatment at the West China Hospital of Stomatology Orthodontic Department.
* Pretreatment lateral cephalometric radiographs showing cervical vertebral maturation stage (CVSM) II or III.
* Patients in the mixed dentition or early permanent dentition stages.
* Class II Division 1 malocclusion according to Angle's classification
* ANB angle \> 4°; SNB ≤ 78°.
* Comprehensive medical records and necessary data available pre- and post-treatment.

Exclusion Criteria

* Missing teeth, supernumerary teeth, or severe dental malformations affecting function.
* Poor oral hygiene.
* Systemic diseases or congenital deformities.
* History of dental or maxillofacial trauma.
* Incomplete or missing records.

Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No