Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar… (NCT07015385) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
40 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
8 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic Assessment of Second Molar Eruption Angle and Position
Timeframe: At baseline and after 12 months of appliance use