MalocclusionEASLALCWNCT06858670
Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars
A study testing Auxiliary Segmental Lingual Appliances in people with Malocclusion and Malocclusion; Displaced or Missing Teeth, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion, Malocclusion; Displaced or Missing Teeth, Malocclusions
- What is being tested?
- Auxiliary Segmental Lingual Appliances
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2025to 1 Mar 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing labial fixed orthodontic treatment.
- Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar).
- Patients willing to participate and provide informed consent.
Who cannot join
- Patients with limited mouth opening and gagging reflex preventing placement of auxiliary segmental lingual appliances.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar) will be recruited.. Using a split-mouth design, one side will receive the intervention (auxiliary segmental lingual appliances), while the other side will serve as the control. The variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. Measurements will be taken on digital impressions at baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after applying the auxiliary segmental lingual appliances. The effectiveness will be assessed by comparing the two groups.
Read the detailed description
This study focuses on evaluating the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The study will recruit patients who exhibit an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar). A split-mouth design will be employed, where one side of the mouth will receive the intervention (auxiliary segmental lingual appliances), and the other side will serve as the control.
The primary variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. These measurements will be taken using digital impressions at three different time points: baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after the application of the auxiliary segmental lingual appliances.
The study aims to compare the effectiveness of the auxiliary segmental lingual appliances by analyzing the differences between the intervention and control sides. This comparison will help determine the impact of the appliances on achieving a more balanced and functional occlusal plane, potentially improving orthodontic treatment outcomes for patients with malocclusion issues.
- Conditions
- Malocclusion, Malocclusion; Displaced or Missing Teeth, Malocclusions, Orthodontic Treatment
- Being tested
- Auxiliary Segmental Lingual Appliances
- Keywords
- Auxiliary Segmental Lingual Appliances, Curve of Wilson, Second Molars, Labial Fixed Orthodontic Treatment, Split-Mouth Design, Digital Impressions, Malocclusion, Dental Occlusion, Orthodontic Treatment Outcomes
- Medical subject headings
- Malocclusion, Anodontia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxiliary Segmental Lingual AppliancesProcedure or surgery
This intervention involves the use of auxiliary segmental lingual appliances specifically designed to level the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The primary goal is to adjust the lingual inclination of the mandibular second molar, thereby achieving a more balanced and functional occlusal plane.
| Study group | Role | What they receive |
|---|---|---|
| Auxiliary Segmental Lingual Appliances Intervention in One Side | Experimental | In this arm, patients will receive the intervention of auxiliary segmental lingual appliances on one side of the mouth. The intervention aims to level the Curve of Wilson by adjusting the lingual inclination and leveling the lingual cusps of the mandibular second molar. Receives: Procedure: Auxiliary Segmental Lingual Appliances |
| Control in Another Side | No intervention | In this arm, patients will not receive the intervention of auxiliary segmental lingual appliances on another side of the mouth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve of Wilson at Second Molar
This measure evaluates the angle between the occlusal plane of the second molar and the mandibular arch occlusal plane. Measurements will be taken using digital impressions.
Measured: Baseline, 6 months, 9 months.
Distance from Mesiolingual Cusp of Second Molar to Occlusal Plane of First Molar
This measure evaluates the distance from the mesiolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.
Measured: Baseline, 6 months, 9 months.
Distance from Distolingual Cusp of Second Molar to Occlusal Plane of First Molar
Description: This measure evaluates the distance from the distoolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.
Measured: Baseline, 6 months, 9 months.
Secondary outcomes (1)
Curve of Wilson at First Molar
Description: This measure evaluates the angle between the occlusal plane of the second molar and the mandibular arch occlusal plane. Measurements will be taken using digital impressions.
Measured: Baseline, 6 months, 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Ngoc Hoa, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858670
- Sponsor's protocol ID
- 240304
- Acronym
- EASLALCW
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars
- ClinicalTrials.gov ID
- NCT06858670
- Acronym / sponsor ID
- EASLALCW / 240304
- Conditions
- Malocclusion, Malocclusion; Displaced or Missing Teeth, Malocclusions, Orthodontic Treatment
- Keywords
- Auxiliary Segmental Lingual Appliances, Curve of Wilson, Second Molars, Labial Fixed Orthodontic Treatment, Split-Mouth Design, Digital Impressions, Malocclusion, Dental Occlusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 5 Mar 2025 (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.
This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar) will be recruited.. Using a split-mouth design, one side will receive the intervention (auxiliary segmental lingual appliances), while the other side will serve as the control. The variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. Measurements will be taken on digital impressions at baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after applying the auxiliary segmental lingual appliances. The effectiveness will be assessed by comparing the two groups.
Detailed description
This study focuses on evaluating the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The study will recruit patients who exhibit an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar). A split-mouth design will be employed, where one side of the mouth will receive the intervention (auxiliary segmental lingual appliances), and the other side will serve as the control.
The primary variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. These measurements will be taken using digital impressions at three different time points: baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after the application of the auxiliary segmental lingual appliances.
The study aims to compare the effectiveness of the auxiliary segmental lingual appliances by analyzing the differences between the intervention and control sides. This comparison will help determine the impact of the appliances on achieving a more balanced and functional occlusal plane, potentially improving orthodontic treatment outcomes for patients with malocclusion issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auxiliary Segmental Lingual Appliances Intervention in One Side | Experimental | Procedure: Auxiliary Segmental Lingual AppliancesIn this arm, patients will receive the intervention of auxiliary segmental lingual appliances on one side of the mouth. The intervention aims to level the Curve of Wilson by adjusting the lingual inclination and leveling the lingual cusps of the mandibular second molar. |
| Control in Another Side | No intervention | –In this arm, patients will not receive the intervention of auxiliary segmental lingual appliances on another side of the mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing labial fixed orthodontic treatment.
- Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar).
- Patients willing to participate and provide informed consent.
Key exclusion criteria (1 listed)
- Patients with limited mouth opening and gagging reflex preventing placement of auxiliary segmental lingual appliances.
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 |
|---|---|---|
| Auxiliary Segmental Lingual AppliancesThis intervention involves the use of auxiliary segmental lingual appliances specifically designed to level the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The primary goal is to adjust the lingual inclination of the mandibular second molar, thereby achieving a more balanced and functional occlusal plane. | Procedure or surgery | Auxiliary Segmental Lingual Appliances Intervention in One Side |
Primary outcome
Curve of Wilson at Second Molar
Time frame: Baseline, 6 months, 9 months.
This measure evaluates the angle between the occlusal plane of the second molar and the mandibular arch occlusal plane. Measurements will be taken using digital impressions.
Distance from Mesiolingual Cusp of Second Molar to Occlusal Plane of First Molar
Time frame: Baseline, 6 months, 9 months.
This measure evaluates the distance from the mesiolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.
Distance from Distolingual Cusp of Second Molar to Occlusal Plane of First Molar
Time frame: Baseline, 6 months, 9 months.
Description: This measure evaluates the distance from the distoolingual cusp of the second molar to the occlusal plane of the first molar. Measurements will be taken using digital impressions.
1 secondary outcome
Curve of Wilson at First Molar
Time frame: Baseline, 6 months, 9 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Auxiliary Segmental Lingual Appliances in people with Malocclusion and Malocclusion; Displaced or Missing Teeth, run by Hanoi Medical University at 1 site in Vietnam.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 18 Sep 2026. 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 Vietnam. 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 was withdrawn before enrolling participants, so there are no results.
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?
Curve of Wilson at Second Molar (time frame: Baseline, 6 months, 9 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.