Clinical trial NCT07015385: Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
Official title: Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bite
Orthodontics
Keywords: Malocclusion
Angle Class II
Deep Bite
Child
Lead sponsor: Dar Al Uloom University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed description: This clinical research study is focused on improving early orthodontic care for children who have an anterior deep bite-a condition where the upper teeth excessively overlap the lower front teeth-and are at risk of second molar impaction, a complication where the posterior teeth do not emerge properly. Left untreated, these issues can lead to long-term dental problems including poor bite alignment, crowding, or the need for surgical intervention.

Orthodontists often use a device called a lip bumper to reduce pressure from the lips on the lower front teeth, making room for crowded teeth and promoting healthy jaw development. However, a well-known downside of using a lip bumper-especially in young children-is that it can cause the first molars to drift forward. This forward movement can block the path for the second molars, increasing the risk that they will not erupt normally.

This study introduces a novel orthodontic appliance that aims to solve both problems at once. The new device combines the benefits of a traditional lip bumper with a "distal shoe"-a small guiding component that helps maintain proper space for the second molars to erupt. By doing so, it seeks not only to correct deep bite problems but also to prevent the common and serious issue of molar impaction.

The study will involve children between the ages of 8 and 10, a key stage of dental development. Participants will receive either the new dual-purpose device or a standard lip bumper and will be monitored over the course of a year. Throughout this period, researchers will examine how the teeth are moving, whether the posterior molars are erupting properly, and how well the deep bite is improving.

In addition to clinical evaluations, the study will gather feedback from children and their parents about comfort, ease of use, and any issues related to the appliance. Understanding patient experience is a vital part of assessing whether this new approach can be widely recommended in pediatric dental care.

Ultimately, this research aims to offer a more comprehensive and preventive solution for young patients undergoing early orthodontic treatment. If the new appliance proves effective, it could significantly reduce the need for more complex procedures later in life and promote better long-term dental health.

Ethical safeguards, including informed consent from parents and assent from participating children, are in place to ensure safety and understanding. The study has received institutional ethics approval and will be conducted under regular clinical monitoring.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Radiographic Assessment of Second Molar Eruption Angle and Position
timeFrame: At baseline and after 12 months of appliance use
Secondary outcomes:
measure: Change in Overbite (in mm)
timeFrame: Baseline and 12 months
measure: Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees
timeFrame: Baseline and 12 months
measure: Visual Analog Scale for Orthodontic Comfort and Tolerance (0-10 scale) Patient-Reported Comfort and Appliance Tolerance
timeFrame: 1 week, 6 weeks, 3 months, and 12 months
measure: Orthodontic Appliance Compliance Assessment Scale (0-5 scale)
timeFrame: at each follow-up visit (every 6 weeks)
measure: Soft Tissue Reaction Severity Scale (0-3 score per site)
timeFrame: At each 6-week follow-up visit
Other outcomes:
Locations:
Study officials:
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