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

NCT07015385 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

DEVICE

Lip Bumper with Integrated Distal Shoe

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.

DEVICE

Conventional Lip Bumper

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.

Sponsors & Collaborators

  • Dar Al Uloom University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-07-15
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015385 on ClinicalTrials.gov