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

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

July 15, 2026

Study Completion Date

November 30, 2026

Conditions
BiteOrthodontics
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.

All Listed Sponsors
lead

Dar Al Uloom University

OTHER