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

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.

NCT Number	NCT07015385
Lead Sponsor	Dar Al Uloom University
Conditions	Bite, Orthodontics
Enrollment	40 participants
Start Date	2025-09-15
Primary Completion	2026-07-15 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2025-08-22