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

NCT06858670 | Recruiting

• 1 other identifier: 240304
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 6 months, 9 months.

Secondary Outcomes (1)

• Curve of Wilson at First Molar

  Baseline, 6 months, 9 months.

Study Arms (2)

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.

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.

Interventions

Auxiliary Segmental Lingual Appliances PROCEDURE

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.

Auxiliary Segmental Lingual Appliances Intervention in One Side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Phenikaa University

Hanoi, 12116, Vietnam

RECRUITING

MeSH Terms

Conditions

Malocclusion; Anodontia; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Viet Anh Nguyen, DDS, MS

CONTACT

+84984822484; anh.nguyenviet1@phenikaa-uni.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)