Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite

NCT07015385 | Not Yet Recruiting DMC

• 1 other identifier: 33-06-2025
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a novel lip bumper with an integrated distal shoe in preventing second molar impaction in children aged 8-10 years with anterior open bite during the mixed dentition stage. The main questions it aims to answer are:

• Does the integrated distal shoe significantly reduce the risk of second molar impaction compared to conventional lip bumpers?
• Does the appliance improve anterior open bite correction and influence lower incisor inclination? Researchers will compare Group I (lip bumper with distal shoe) to Group II (conventional lip bumper) to see if the modified appliance prevents mesial drift of first molars and improves eruption outcomes of second molars. Participants will:
• Undergo initial records including panoramic and cephalometric radiographs, study models, and intraoral photos
• Be fitted with one of the two appliances and followed up every 6 weeks over a 12-month period
• Receive radiographic and clinical evaluation of second molar eruption
• Complete assessments related to overbite changes, incisor inclination, comfort, and compliance This trial seeks to inform early orthodontic protocols and may offer a dual-function solution for both molar guidance and open bite correction.

Conditions

Bite; Orthodontics

Keywords

Malocclusion; Angle Class II; Deep Bite; Child

Outcome Measures

Primary Outcomes (1)

• Radiographic Assessment of Second Molar Eruption Angle and Position

  Radiographic Eruption Angle Measurement Scale (in degrees) Objectives: To evaluate the effect of the appliance on the eruption trajectory and final position of the second permanent molars, using radiographic measurements to detect impaction or favorable eruption patterns. * Measurement Method: Panoramic radiograph using digital angle analysis tools to measure the angle between the long axis of the second molar and a stable reference line (e.g., occlusal plane or mandibular base). * Scale Range: * Minimum value: 0° (perfect vertical eruption) * Maximum value: \~90° (severely impacted or horizontal position) * Interpretation: * Lower scores (closer to 0°) indicate a more favorable eruption position and vertical alignment. * Higher scores (closer to 90°) indicate a worse outcome, suggesting impaction or abnormal angulation. Angular and positional changes of the mandibular second permanent molars (in degrees or millimeters) as observed on standardized panoramic radiographs

  At baseline and after 12 months of appliance use

Secondary Outcomes (5)

• Change in Overbite (in mm)

  Baseline and 12 months

• Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees

  Baseline and 12 months

• Visual Analog Scale for Orthodontic Comfort and Tolerance (0-10 scale) Patient-Reported Comfort and Appliance Tolerance

  1 week, 6 weeks, 3 months, and 12 months

• Orthodontic Appliance Compliance Assessment Scale (0-5 scale)

  at each follow-up visit (every 6 weeks)

• Soft Tissue Reaction Severity Scale (0-3 score per site)

  At each 6-week follow-up visit

Study Arms (2)

Lip Bumper with Integrated Distal Shoe

EXPERIMENTAL

Participants in this group will receive a novel orthodontic appliance that combines a traditional lip bumper with an integrated distal shoe. The appliance is designed to prevent mesial migration of the first molars and guide proper eruption of the second permanent molars. It also functions to relieve anterior deep bite by reducing lip pressure and promoting vertical and sagittal arch development. The appliance will be worn continuously for a period of 12 months with follow-up visits every 6 weeks for adjustments and monitoring.

Device: Lip Bumper with Integrated Distal Shoe

Conventional Lip Bumper

ACTIVE COMPARATOR

Participants in this group will receive a standard lip bumper appliance, commonly used in interceptive orthodontics to relieve lower arch crowding and eliminate lip pressure. This appliance does not include any mechanism to prevent mesial drift of the first molars or guide the eruption path of second molars. It will be used in the same time frame and follow-up schedule as the experimental group to allow direct comparison of outcomes.

Device: Conventional Lip Bumper

Interventions

Lip Bumper with Integrated Distal Shoe DEVICE

This novel appliance integrates a traditional lip bumper with a distal shoe extension designed to engage the mesial surface of the unerupted second permanent molar. The goal is to prevent mesial movement of the first molars and guide proper eruption of the second molars while simultaneously addressing anterior deep bite by eliminating lip pressure and promoting vertical incisor development. The device will be custom-fabricated for each participant and will be worn for 12 months, with clinical and radiographic evaluations conducted every 6 weeks.

Lip Bumper with Integrated Distal Shoe

Conventional Lip Bumper DEVICE

The conventional lip bumper is an interceptive orthodontic appliance used to alleviate lower anterior crowding, eliminate perioral muscle pressure, and promote dental arch expansion. It does not include a distal shoe component and therefore offers no guidance for second molar eruption. This device will also be custom-fabricated and worn for 12 months, with scheduled monitoring every 6 weeks to assess treatment progress and compare outcomes with the experimental device.

Conventional Lip Bumper

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 8 and 11 years
• In mixed dentition stage (presence of permanent first molars and incisors; unerupted second molars)
• Presence of an anterior deep bite of ≥ 2 mm (measured vertically between upper and lower incisors)
• Class I or mild Class II malocclusion
• Good general health with no systemic conditions that may affect dental development or treatment
• Written informed consent obtained from the parent or legal guardian and assent from the child

You may not qualify if:

• History of previous orthodontic treatment
• Presence of craniofacial anomalies (e.g., cleft lip/palate) or syndromic conditions
• Diagnosis of systemic diseases that affect bone metabolism or craniofacial growth (e.g., juvenile rheumatoid arthritis, osteogenesis imperfecta)
• Evidence of poor oral hygiene or active caries requiring urgent dental care
• Use of any medication known to affect dental development (e.g., long-term corticosteroids, antiepileptics)
• Behavioral or developmental disorders that would preclude cooperation with appliance wear or study procedures

Sponsors & Collaborators

• Dar Al Uloom University: lead

MeSH Terms

Conditions

Bites and Stings; Malocclusion; Malocclusion, Angle Class II; Overbite

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Sally A ElHaddad, Assist. Prof.

CONTACT

+966555361062; s.elhaddad@dau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: Parallel Assignment This clinical trial will follow a parallel assignment model, meaning participants will be randomly assigned to one of two independent groups, and each group will receive a distinct intervention throughout the duration of the study. There will be no crossover between groups. Group Assignments: Group I (Experimental Group): Participants will receive a lip bumper integrated with a distal shoe. This novel appliance aims to maintain space for the second molars and guide their eruption while simultaneously addressing anterior deep bite. Group II (Control Group): Participants will receive a conventional lip bumper, the standard interceptive appliance used to relieve lip pressure and promote arch development without specific design elements to prevent molar impaction. Key Characteristics of the Study Model: Allocation: Randomized Intervention Duration: 12 months Follow-Up Visits: Every 6 weeks

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD Availability Timeline Start Date for IPD Availability: Six months after publication of the primary study results in a peer-reviewed journal. End Date for IPD Availability: Five years from the start date of data sharing. During this period, de-identified individual participant data and related supporting documents (such as the study protocol and statistical analysis plan) will be made available to qualified researchers upon reasonable request and subject to data use agreements.