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

NCT ID: NCT06858670

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2029-03-01

Brief Summary

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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

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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

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Malocclusion Malocclusion; Displaced or Missing Teeth Malocclusions Orthodontic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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).

Study Groups

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Auxiliary Segmental Lingual Appliances Intervention in One Side

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.

Group Type EXPERIMENTAL

Auxiliary Segmental Lingual Appliances

Intervention Type 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.

Control in Another Side

In this arm, patients will not receive the intervention of auxiliary segmental lingual appliances on another side of the mouth.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auxiliary 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanoi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nguyen Ngoc Hoa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Phenikaa University

Hanoi, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Viet Anh Nguyen, DDS, MS

Role: CONTACT

+84984822484

Facility Contacts

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Viet Anh Nguyen

Role: primary

+84984822484

Other Identifiers

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240304

Identifier Type: -

Identifier Source: org_study_id

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