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

NCT06609733 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2024-09-24

No results posted yet for this study

Summary

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.

Conditions

  • CLASS II DIVISION 1 MALOCCLUSION

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-08-01
Completion
2024-06-30
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06609733 on ClinicalTrials.gov