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Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars

Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858670
Acronym
EASLALCW
Enrollment
0
Registered
2025-03-05
Start date
2025-03-01
Completion date
2029-03-01
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, Orthodontic Treatment Outcomes

Brief 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. 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.

Interventions

PROCEDUREAuxiliary Segmental Lingual Appliances

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.

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

There will be no masking in this study. Both the patient and the outcome assessor will know which side will receive the intervention (auxiliary segmental lingual appliances).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients with limited mouth opening and gagging reflex preventing placement of auxiliary segmental lingual appliances.

Design outcomes

Primary

MeasureTime frameDescription
Curve of Wilson at Second MolarBaseline, 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 MolarBaseline, 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 MolarBaseline, 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.

Secondary

MeasureTime frameDescription
Curve of Wilson at First MolarBaseline, 6 months, 9 months.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.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026