CLASS II DIVISION 1 MALOCCLUSIONNCT06609733
Comparative Effect of Clear Aligner Mandibular Advancement and Twin Block Appliances in Class II Malocclusion
An observational study of CLASS II DIVISION 1 MALOCCLUSION, run by Sichuan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- Twin block and Clear aligner with mandibular function
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
West China School of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
About this study
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:
- Does mandibular advancement with clear aligners improve jaw and dental alignment as effectively as Twin Block appliances?
- What are the differences in soft tissue changes, such as chin advancement and lip position, between these two treatments?
Read more
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.
Read the 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.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- Twin block, Clear aligner with mandibular function
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin blockDevice
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.
Clear aligner with mandibular functionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MA group | Patients receiving routine care for Class II malocclusion, which may include the use of Clear Aligner with Mandibular Advancement (MA) function appliances Receives: Device: Clear aligner with mandibular function | |
| TB group | Patients receiving routine care for Class II malocclusion, which may include the use of Twin Block (TB) appliances Receives: Device: Twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Skeletal Measurements ( SNB angle)
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the SNB angle, a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Measured: 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.
Changes in Soft Tissue Measurements ( soft tissue chin thickness)
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the soft tissue chin thickness, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts (baseline) and after the treatment concludes (1-2 weeks post the 12-month treatment). This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Measured: 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.
Changes in Skeletal Measurements (ANB angle)
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the ANB angle, a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Measured: 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.
Changes in Skeletal Measurements ( mandibular length)
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the mandibular length (mm), a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Aug 2021
- Primary completion1 Aug 2022
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CLASS II DIVISION 1 MALOCCLUSIONStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijun Tan, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609733
- Sponsor's protocol ID
- WCHS-IRB-CT-2023-195
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: confidential
Publications
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.
PubMed 35094890
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Clear Aligner Mandibular Advancement and Twin Block Appliances in Class II Malocclusion
- ClinicalTrials.gov ID
- NCT06609733
- Acronym / sponsor ID
- WCHS-IRB-CT-2023-195
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does mandibular advancement with clear aligners improve jaw and dental alignment as effectively as Twin Block appliances?
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MA group | – | Device: Clear aligner with mandibular functionPatients receiving routine care for Class II malocclusion, which may include the use of Clear Aligner with Mandibular Advancement (MA) function appliances |
| TB group | – | Device: Twin blockPatients receiving routine care for Class II malocclusion, which may include the use of Twin Block (TB) appliances |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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°.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twin blockThe 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 | TB group |
| Clear aligner with mandibular functionThe 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. | Device | MA group |
Primary outcome
Changes in Skeletal Measurements ( SNB angle)
Time frame: 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.
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the SNB angle, a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Changes in Soft Tissue Measurements ( soft tissue chin thickness)
Time frame: 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.
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the soft tissue chin thickness, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts (baseline) and after the treatment concludes (1-2 weeks post the 12-month treatment). This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Changes in Skeletal Measurements (ANB angle)
Time frame: 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.
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the ANB angle, a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Changes in Skeletal Measurements ( mandibular length)
Time frame: 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
This study assesses skeletal changes in patients treated for Class II malocclusion with Twin Block (TB) or Mandibular Advancement (MA) appliances at West China School of Stomatology, Sichuan University. The evaluation focuses on the measurement of the mandibular length (mm), a critical skeletal parameter, using cephalometric radiographs. These radiographs are taken as a routine part of the treatment to capture skeletal positioning before the treatment starts and after the treatment concludes. This allows for an analysis of the angular changes due to the orthodontic intervention, providing insights into the effectiveness of the appliances in correcting malocclusions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Results publication: PubMed 35094890Alsaggaf 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.
- Individual participant dataSharing planned: No. confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLASS II DIVISION 1 MALOCCLUSION, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Skeletal Measurements ( SNB angle) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06609733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.