BiteNovel Lip BumpNCT07015385
Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
A study testing Lip Bumper with Integrated Distal Shoe and Conventional Lip Bumper in people with Bite and Orthodontics, run by Dar Al Uloom University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Bite, Orthodontics
- What is being tested?
- Lip Bumper with Integrated Distal Shoe and Conventional Lip Bumper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Bite, Orthodontics
- Being tested
- Lip Bumper with Integrated Distal Shoe, Conventional Lip Bumper
- Keywords
- Malocclusion, Angle Class II, Deep Bite, Child
- Medical subject headings
- Bites and Stings, Malocclusion, Malocclusion, Angle Class II, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip Bumper with Integrated Distal ShoeDevice
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 BumperDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lip Bumper with Integrated Distal Shoe | Experimental | 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. Receives: Device: Lip Bumper with Integrated Distal Shoe |
| Conventional Lip Bumper | Active comparator | 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. Receives: Device: Conventional Lip Bumper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and after 12 months of appliance use
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
- 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
Measured: 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
- 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
Measured: At each 6-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment This clinical trial will follow a parallel assignment model, meaning participants will be randomly assigned to one of two independent groups, and each group will receive a distinct intervention throughout the duration of the study. There will be no crossover between groups. Group Assignments: Group I (Experimental Group): Participants will receive a lip bumper integrated with a distal shoe. This novel appliance aims to maintain space for the second molars and guide their eruption while simultaneously addressing anterior deep bite. Group II (Control Group): Participants will receive a conventional lip bumper, the standard interceptive appliance used to relieve lip pressure and promote arch development without specific design elements to prevent molar impaction. Key Characteristics of the Study Model: Allocation: Randomized Intervention Duration: 12 months Follow-Up Visits: Every 6 weeks
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015385
- Sponsor's protocol ID
- 33-06-2025
- Acronym
- Novel Lip Bump
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
- ClinicalTrials.gov ID
- NCT07015385
- Acronym / sponsor ID
- Novel Lip Bump / 33-06-2025
- Conditions
- Bite, Orthodontics
- Keywords
- Malocclusion, Angle Class II, Deep Bite, Child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment This clinical trial will follow a parallel assignment model, meaning participants will be randomly assigned to one of two independent groups, and each group will receive a distinct intervention throughout the duration of the study. There will be no crossover between groups. Group Assignments: Group I (Experimental Group): Participants will receive a lip bumper integrated with a distal shoe. This novel appliance aims to maintain space for the second molars and guide their eruption while simultaneously addressing anterior deep bite. Group II (Control Group): Participants will receive a conventional lip bumper, the standard interceptive appliance used to relieve lip pressure and promote arch development without specific design elements to prevent molar impaction. Key Characteristics of the Study Model: Allocation: Randomized Intervention Duration: 12 months Follow-Up Visits: Every 6 weeks
| Arm | Type | Receives |
|---|---|---|
| Lip Bumper with Integrated Distal Shoe | Experimental | Device: Lip Bumper with Integrated Distal ShoeParticipants 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. |
| Conventional Lip Bumper | Active comparator | Device: Conventional Lip BumperParticipants 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lip Bumper with Integrated Distal ShoeThis 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. | Device | Lip Bumper with Integrated Distal Shoe |
| Conventional Lip BumperThe 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. | Device | Conventional Lip Bumper |
Primary outcome
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
5 secondary outcomes
Change in Overbite (in mm)
Time frame: Baseline and 12 months
Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees
Time frame: Baseline and 12 months
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
Orthodontic Appliance Compliance Assessment Scale (0-5 scale)
Time frame: at each follow-up visit (every 6 weeks)
Soft Tissue Reaction Severity Scale (0-3 score per site)
Time frame: At each 6-week follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lip Bumper with Integrated Distal Shoe and Conventional Lip Bumper in people with Bite and Orthodontics, run by Dar Al Uloom University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sally A ElHaddad, Assist. Prof. (+966555361062, s.elhaddad@dau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Assessment of Second Molar Eruption Angle and Position (time frame: At baseline and after 12 months of appliance use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.