An interventional study of Lip Bumper with Integrated Distal Shoe and Conventional Lip Bumper in Bite and Orthodontics, sponsored by Dar Al Uloom University. Not yet recruiting. Open to participants aged 8 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Dar Al Uloom University · Not applicable, Interventional, and Treatment
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:
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:
This clinical research study is focused on improving early orthodontic care for children who have an anterior deep bite-a condition where the upper teeth excessively overlap the lower front teeth-and are at risk of second molar impaction, a complication where the posterior teeth do not emerge properly. Left untreated, these issues can lead to long-term dental problems including poor bite alignment, crowding, or the need for surgical intervention.
Orthodontists often use a device called a lip bumper to reduce pressure from the lips on the lower front teeth, making room for crowded teeth and promoting healthy jaw development. However, a well-known downside of using a lip bumper-especially in young children-is that it can cause the first molars to drift forward. This forward movement can block the path for the second molars, increasing the risk that they will not erupt normally.
This study introduces a novel orthodontic appliance that aims to solve both problems at once. The new device combines the benefits of a traditional lip bumper with a "distal shoe"-a small guiding component that helps maintain proper space for the second molars to erupt. By doing so, it seeks not only to correct deep bite problems but also to prevent the common and serious issue of molar impaction.
The study will involve children between the ages of 8 and 10, a key stage of dental development. Participants will receive either the new dual-purpose device or a standard lip bumper and will be monitored over the course of a year. Throughout this period, researchers will examine how the teeth are moving, whether the posterior molars are erupting properly, and how well the deep bite is improving.
In addition to clinical evaluations, the study will gather feedback from children and their parents about comfort, ease of use, and any issues related to the appliance. Understanding patient experience is a vital part of assessing whether this new approach can be widely recommended in pediatric dental care.
Ultimately, this research aims to offer a more comprehensive and preventive solution for young patients undergoing early orthodontic treatment. If the new appliance proves effective, it could significantly reduce the need for more complex procedures later in life and promote better long-term dental health.
Ethical safeguards, including informed consent from parents and assent from participating children, are in place to ensure safety and understanding. The study has received institutional ethics approval and will be conducted under regular clinical monitoring.
22 studies on the registry are indexed under Bites and Stings; 7 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 19 interventional studies indexed under Bites and Stings.
Browse Bites and Stings studies →Dar Al Uloom University is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive a novel orthodontic appliance that combines a traditional lip bumper with an integrated distal shoe. The appliance is designed to prevent mesial migration of the first molars and guide proper eruption of the second permanent molars. It also functions to relieve anterior deep bite by reducing lip pressure and promoting vertical and sagittal arch development. The appliance will be worn continuously for a period of 12 months with follow-up visits every 6 weeks for adjustments and monitoring.
Device: Lip Bumper with Integrated Distal Shoe
Participants in this group will receive a standard lip bumper appliance, commonly used in interceptive orthodontics to relieve lower arch crowding and eliminate lip pressure. This appliance does not include any mechanism to prevent mesial drift of the first molars or guide the eruption path of second molars. It will be used in the same time frame and follow-up schedule as the experimental group to allow direct comparison of outcomes.
Device: Conventional Lip Bumper
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.
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.
Radiographic Assessment of Second Molar Eruption Angle and Position
Radiographic Eruption Angle Measurement Scale (in degrees) Objectives: To evaluate the effect of the appliance on the eruption trajectory and final position of the second permanent molars, using radiographic measurements to detect impaction or favorable eruption patterns. * Measurement Method: Panoramic radiograph using digital angle analysis tools to measure the angle between the long axis of the second molar and a stable reference line (e.g., occlusal plane or mandibular base). * Scale Range: * Minimum value: 0° (perfect vertical eruption) * Maximum value: \~90° (severely impacted or horizontal position) * Interpretation: * Lower scores (closer to 0°) indicate a more favorable eruption position and vertical alignment. * Higher scores (closer to 90°) indicate a worse outcome, suggesting impaction or abnormal angulation. Angular and positional changes of the mandibular second permanent molars (in degrees or millimeters) as observed on standardized panoramic radiographs
Time frame: At baseline and after 12 months of appliance use
Change in Overbite (in mm)
Measurement Method: Measured on study models from the incisal edge of the maxillary central incisor to the incisal edge of the opposing mandibular incisor at the point of greatest overlap, when posterior teeth are in occlusion. Scale Range: Minimum value: 0 mm (edge-to-edge or open bite) Maximum value: Typically up to 6-8 mm (deep bite), depending on the patient's anatomy Interpretation: Lower scores after treatment indicate improvement (reduced deep bite), representing a better clinical outcome Higher scores after treatment suggest persistence or worsening of the deep bite, representing a worse clinical outcome
Time frame: Baseline and 12 months
Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees
Measurement Method: IMPA is measured on standardized lateral cephalometric radiographs as the angle between the long axis of the most prominent mandibular central incisor and the mandibular plane (typically drawn from gonion to menton). Scale Range: Minimum value: \~80° (retroclined lower incisors) Maximum value: \~110° (proclined lower incisors) (Typical normal range: 90° ± 5°) Interpretation: Lower scores (e.g., \< 85°) indicate retroclination of the lower incisors Higher scores (e.g., \> 95°) indicate proclination
Time frame: Baseline and 12 months
Visual Analog Scale for Orthodontic Comfort and Tolerance (0-10 scale) Patient-Reported Comfort and Appliance Tolerance
Patients will complete a self-reported questionnaire at specified intervals (1 week, 6 weeks, 3 months, and 12 months) rating their comfort and tolerance of the appliance. The scale used is a Visual Analog Scale (VAS) ranging from 0 to 10. Scale Range: Maximum value: 10 = No comfort at all / appliance is very uncomfortable and intolerable Minimum value: 0 = Very comfortable / appliance is completely tolerable Interpretation: Lower scores indicate better outcomes, reflecting greater comfort and tolerance to the appliance Higher scores suggest discomfort, poor adaptation, or potential complications impacting patient compliance
Time frame: 1 week, 6 weeks, 3 months, and 12 months
Orthodontic Appliance Compliance Assessment Scale (0-5 scale)
Orthodontist will assess patient compliance based on appliance wear, cleanliness, and adherence to instructions. Scoring will be based on clinical observation and patient self-report, using a standardized 6-point scale. Scale Range: 0: Non-compliant - never wears appliance or refuses treatment 1. Very poor compliance - wears appliance \<25% of the time 2. Poor compliance - inconsistent use, visible neglect of hygiene 3. Moderate compliance - wears appliance \~50-75% of expected time 4. Good compliance - minor lapses in wear or cleaning 5. Excellent compliance - wears appliance as instructed, maintains hygiene Interpretation: Higher scores (4-5) reflect better outcomes, indicating strong adherence to treatment and greater likelihood of therapeutic success Lower scores (0-2) indicate poor cooperation, which may reduce treatment effectiveness
Time frame: at each follow-up visit (every 6 weeks)
Soft Tissue Reaction Severity Scale (0-3 score per site)
Clinical examination will be performed to assess the soft tissues adjacent to the appliance. Adverse reactions such as ulceration, erythema, swelling, and hyperplasia will be documented using a standardized 4-point severity scale. Scale Range: 0: No reaction - healthy tissue 1. Mild - slight redness or irritation, no ulceration 2. Moderate - noticeable inflammation, small ulcers or discomfort 3. Severe - pronounced ulceration, swelling, or tissue overgrowth requiring intervention Interpretation: Lower scores (0-1) indicate better outcomes, reflecting good appliance biocompatibility and patient adaptation Higher scores (2-3) indicate worse outcomes, signifying poor tissue response or intolerance to the appliance
Time frame: At each 6-week follow-up visit
No study locations are listed for this record.
Plan to share: Yes — The following de-identified individual participant data (IPD) will be shared: Demographic data: age, sex, and baseline dental classification (e.g., type of malocclusion) Radiographic measurements: second molar eruption angle and position at baseline and 12 months Cephalometric data: baseline and post-treatment incisor mandibular plane angle (IMPA) Overbite measurements: baseline and post-treatment vertical overlap (in mm) Patient-reported outcomes: responses from comfort and compliance questionnaires Adverse event reports: type, frequency, and severity of any soft tissue complications Compliance assessments: clinician-rated appliance wear and follow-up adherence All shared data will be fully anonymized in accordance with ethical standards and privacy regulations.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: IPD Availability Timeline Start Date for IPD Availability: Six months after publication of the primary study results in a peer-reviewed journal. End Date for IPD Availability: Five years from the start date of data sharing. During this period, de-identified individual participant data and related supporting documents (such as the study protocol and statistical analysis plan) will be made available to qualified researchers upon reasonable request and subject to data use agreements.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Dar Al Uloom University