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.
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
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
Parallel
Lip Bumper with Integrated Distal Shoe
DeviceThis 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
DeviceThe 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
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
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
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
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
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