Clinical trial NCT06858670: Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars
Official title: Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Curve of Wilson at Second Molar
timeFrame: Baseline, 6 months, 9 months.
measure: Distance from Mesiolingual Cusp of Second Molar to Occlusal Plane of First Molar
timeFrame: Baseline, 6 months, 9 months.
measure: Distance from Distolingual Cusp of Second Molar to Occlusal Plane of First Molar
timeFrame: Baseline, 6 months, 9 months.
Secondary outcomes:
measure: Curve of Wilson at First Molar
timeFrame: Baseline, 6 months, 9 months.
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Phenikaa University
Study officials:
References: