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

Launched by DAR AL ULOOM UNIVERSITY · Jun 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new orthodontic device called a lip bumper with an integrated distal shoe. The aim is to see if this device can help prevent problems with the second molars (the big teeth at the back of the mouth) in children aged 8 to 10 who have a specific type of bite issue known as an anterior deep bite. The researchers want to find out if this new device works better than traditional lip bumpers in making sure the second molars come in properly and in correcting the bite.

To participate in the study, children need to be between 8 and 11 years old and currently have a mix of baby and permanent teeth, with some specific bite measurements. They will have some initial dental records taken and will then be given one of the two devices to wear. Over the course of a year, they will visit the clinic every six weeks for check-ups, where the researchers will look at how well the second molars are coming in and how the bite is improving. This study could provide valuable information for early orthodontic treatment and might help with both guiding molar growth and correcting the bite issue.

Gender

ALL

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