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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorDar Al Uloom University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lip Bumper with Integrated Distal Shoe
  • Conventional Lip Bumper

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators