Clinical trial NCT06609733: Comparative Effect of Clear Aligner Mandibular Advancement and Twin Block Appliances in Class II Malocclusion
Official title: Comparative Effect of Clear Aligner Mandibular Advancement and Twin Block Appliances in Class II Malocclusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CLASS II DIVISION 1 MALOCCLUSION
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 47
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients from the Orthodontics Department at West China Hospital of Stomatology, Sichuan University. This population includes individuals diagnosed with Class II malocclusion who are undergoing or have completed treatment with Mandibular Advancement (MA) or Twin Block (TB) appliances. Eligible participants for the treatment group are those in the mixed dentition or early permanent dentition stages, showing specific cephalometric characteristics such as an ANB angle greater than 4 degrees and an SNB angle less than or equal to 78 degrees.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 \&gt; 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.

Primary outcomes:
measure: Changes in Skeletal Measurements ( SNB angle)
timeFrame: Baseline and post-treatment cephalometric radiographs will be taken 1-2 weeks pre and 1-2 weeks post the 12-month treatment at West China School of Stomatology, Sichuan University.
measure: Changes in Soft Tissue Measurements ( soft tissue chin thickness)
timeFrame: Baseline and post-treatment cephalometric radiographs will be taken 1-2 weeks pre and 1-2 weeks post the 12-month treatment at West China School of Stomatology, Sichuan University.
measure: Changes in Skeletal Measurements (ANB angle)
timeFrame: Baseline and post-treatment cephalometric radiographs will be taken 1-2 weeks pre and 1-2 weeks post the 12-month treatment at West China School of Stomatology, Sichuan University.
measure: Changes in Skeletal Measurements ( mandibular length)
timeFrame: Baseline and post-treatment cephalometric radiographs will be taken 1-2 weeks pre and 1-2 weeks post the 12-month treatment at West China School of Stomatology, Sichuan University
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China School of Stomatology, Sichuan University
state: Sichuan
Study officials:
References:
citation: Alsaggaf DH, Afify AR, Zawawi KH, Alsulaimani FF. Factors influencing the orthodontic treatment plan in Class II malocclusion. Am J Orthod Dentofacial Orthop. 2022 Jun;161(6):829-837.e1. doi: 10.1016/j.ajodo.2021.01.034. Epub 2022 Jan 29.