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NCT Number: NCT07015385

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

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.

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Key information

Conditions

Bite Bites and Stings Chemically-Induced Disorders Malocclusion Malocclusion, Angle Class II Orthodontics Overbite Poisoning Stomatognathic Diseases Tooth Diseases Wounds and Injuries

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lip Bumper with Integrated Distal Shoe

Device

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.

Conventional Lip Bumper

Device

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.

Primary outcomes

  1. Radiographic Assessment of Second Molar Eruption Angle and Position

    Time frame: At baseline and after 12 months of appliance use

    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

Secondary outcomes

  1. Change in Overbite (in mm)

    Time frame: Baseline and 12 months

    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

  2. Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees

    Time frame: Baseline and 12 months

    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

  3. Visual Analog Scale for Orthodontic Comfort and Tolerance (0-10 scale) Patient-Reported Comfort and Appliance Tolerance

    Time frame: 1 week, 6 weeks, 3 months, and 12 months

    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

  4. Orthodontic Appliance Compliance Assessment Scale (0-5 scale)

    Time frame: at each follow-up visit (every 6 weeks)

    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

    • Very poor compliance - wears appliance <25% of the time
    • Poor compliance - inconsistent use, visible neglect of hygiene
    • Moderate compliance - wears appliance ~50-75% of expected time
    • Good compliance - minor lapses in wear or cleaning
    • 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

  5. Soft Tissue Reaction Severity Scale (0-3 score per site)

    Time frame: At each 6-week follow-up visit

    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

    • Mild - slight redness or irritation, no ulceration
    • Moderate - noticeable inflammation, small ulcers or discomfort
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sally A ElHaddad, Assist. Prof.

CONTACT

[email protected]

+966555361062

Sponsors and collaborators

Lead sponsor

Dar Al Uloom University

Other

Registry information

Acronym: Novel Lip Bump

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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