Oral HabitsNCT06650241
A Clinical Comparative Study of Different Methods for Correcting Lower Lip Sucking Habits in Preschool Children
A study testing Behavioral therapy, Lip Bumper Therapy and Modified Twin-Block Therapy in people with Oral Habits, run by Qingdao University.
Trial summary
Comparison of the Effectiveness of Behavioral Therapy, Maxillary Lip Bumper Appliance, and Twin-Block Appliance in Correcting Lower Lip Sucking Habits in Children Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Habits
- What is being tested?
- Behavioral therapy, Lip Bumper Therapy and Modified Twin-Block Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool children aged 3-6 years,
- Habit of lower lip sucking,
- No anterior crossbite or open bite,
- Missing no more than 2 incisors in a single jaw,
- No other systemic diseases,
- The child's family has a certain level of reading and comprehension ability, can effectively understand the questionnaire content, and is willing to sign the informed consent form.
Who cannot join
- Prior orthodontic treatment;
- Tooth extraction;
- Mini-implant usage;
- Chronic rhinitis, tonsil hypertrophy and other upper airway diseases.
About this study
Comparison of the Effectiveness of Behavioral Therapy, Maxillary Lip Bumper Appliance, and Twin-Block Appliance in Correcting Lower Lip Sucking Habits in Children
Read the detailed description
Intervention Methods Behavioral Therapy Group: Children were rewarded with their favorite candy or toys as positive reinforcement when they refrained from sucking their lower lip. When they exhibited lip-sucking behavior, corresponding punishments were applied (e.g., being prohibited from watching cartoons for 1 hour or from playing with toys) as negative reinforcement. At night, bitter nail polish or substances with unpleasant smells were applied to the lower lip as aversive stimuli. Patients attended follow-up appointments monthly.
Lip Bumper Therapy Group: The treatment involved placing arrow-shaped clasps and interproximal hooks on the maxillary molars, with a double-curved labial bow positioned on the labial side of the upper anterior teeth. A lip bumper wire was soldered at the position of the maxillary central incisors. The lip bumper wire should reach the mandibular vestibular groove to support the lower lip without obstructing the natural labial adjustment of the lower anterior teeth. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments were conducted, during which the double-curved labial bow could be adjusted to retract the upper anterior teeth.
Modified Twin-Block Therapy Group: Initially, occlusal reconstruction was performed, with the combined forward movement of the mandible and vertical dimension being less than 10 mm. The standard criteria were an incisal edge-to-edge bite of the upper and lower anterior teeth, with the vertical opening in the posterior region exceeding the resting occlusal gap by 2-3 mm. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments included progressive grinding of the maxillary occlusal pads. If discrepancies in arch width occurred, expansion therapy was implemented.
Evaluation of Therapeutic Efficacy
All children were assessed for the following indicators after 6 months of treatment:
- Comparison of Lip-Sucking Habit Improvement: The outcome of lip-sucking habit correction was compared among the groups. Treatment was considered successful if the lip-sucking habit was completely corrected, malocclusion was improved, and parents were satisfied. It was considered unsuccessful if there was no significant improvement in the lip-sucking habit and parents were dissatisfied. Success rate = (Number of successful cases / Total number of cases) × 100%.
- Comparison of Oral Examination and Model Analysis Indicators:** Oral examinations and oral model preparation were conducted before treatment (T0) and one month after the end of treatment (T2). Changes in the overjet of the anterior teeth were measured using a vernier caliper.
- Comparison of Cephalometric Measurements:Lateral cephalometric radiographs were taken before treatment (T0) and one month after the end of treatment (T2). SNA, SNB, ANB, U1-SN, and L1-MP angles were measured using Dolphin software (Version 11.8, Dolphin Imaging and Management Solutions, CA, USA).
- Assessment of Oral Health-Related Quality of Life (OHRQoL) using the ECOHIS Questionnaire:The Chinese version of the Early Childhood Oral Health Impact Scale (ECOHIS) was used to assess the impact of lip-sucking habits and orthodontic treatment on children's OHRQoL. Parents completed the ECOHIS questionnaire before treatment (T0), after 1 month of treatment (T1), and 1 month after the end of treatment (T2). The questionnaire includes 13 items, covering the *Child Impact Section* (CIS) which assesses the impact on the child's symptoms, functions, psychology, and social interactions, as well as the *Family Impact Section* (FIS), which assesses the impact on parental distress and family function. Each item is rated on a scale of 0-5: never (0), hardly ever (1), occasionally (2), often (3), very often (4), don't know (5). The total ECOHIS score is calculated by summing the response codes from both CIS and FIS sections. The score ranges from 0 to 65, with higher scores indicating a greater negative impact on children's OHRQoL. The questionnaire was considered invalid if there were more than two "don't know" responses in the CIS or one in the FIS, and another child was selected for inclusion.
- Conditions
- Oral Habits
- Being tested
- Behavioral therapy, Lip Bumper Therapy, Modified Twin-Block Therapy
- Keywords
- preschool children, Oral Health-Related Quality of Life (OHRQoL), Early Childhood Oral Health Impact Scale (ECOHIS),
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral therapyOther
Lip Bumper TherapyOther
Modified Twin-Block TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Behavioral therapy | Experimental | Behavioral Therapy Group: Children were rewarded with their favorite candy or toys as positive reinforcement when they refrained from sucking their lower lip. When they exhibited lip-sucking behavior, corresponding punishments were applied (e.g., being prohibited from watching cartoons for 1 hour or from playing with toys) as negative reinforcement. At night, bitter nail polish or substances with unpleasant smells were applied to the lower lip as aversive stimuli. Patients attended follow-up appointments monthly. Receives: Other: Behavioral therapy |
| Maxillary lip bumper appliance | Experimental | Lip Bumper Therapy Group: The treatment involved placing arrow-shaped clasps and interproximal hooks on the maxillary molars, with a double-curved labial bow positioned on the labial side of the upper anterior teeth. A lip bumper wire was soldered at the position of the maxillary central incisors. The lip bumper wire should reach the mandibular vestibular groove to support the lower lip without obstructing the natural labial adjustment of the lower anterior teeth. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments were conducted, during which the double-curved labial bow could be adjusted to retract the upper anterior teeth. Receives: Other: Lip Bumper Therapy |
| Twin-block | Experimental | Modified Twin-Block Therapy Group: Initially, occlusal reconstruction was performed, with the combined forward movement of the mandible and vertical dimension being less than 10 mm. The standard criteria were an incisal edge-to-edge bite of the upper and lower anterior teeth, with the vertical opening in the posterior region exceeding the resting occlusal gap by 2-3 mm. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments included progressive grinding of the maxillary occlusal pads. If discrepancies in arch width occurred, expansion therapy was implemented. Receives: Other: Modified Twin-Block Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overjet
Overjet refers to the horizontal distance between the front edge of the upper front teeth (maxillary incisors) and the front edge of the lower front teeth (mandibular incisors). In a normal alignment, the upper front teeth slightly overlap the lower front teeth, but when this overlap is excessive, it results in a noticeable overjet.
From a side view, overjet is measured as the horizontal distance between the upper and lower front teeth, typically in millimeters. A normal overjet is usually around 2-3 millimeters. If the distance is greater than this, it is considered abnormal. A large overjet can lead to issues with bite alignment, aesthetics, and function, such as difficulties with eating or speaking, and increased vulnerability to trauma.
Measured: 6 months
ANB
ANB is an angle measurement used in orthodontics and cephalometrics to evaluate the relative position of the maxilla (upper jaw) to the mandible (lower jaw). It is derived from the difference between the SNA and SNB angles:
S (Sella): The center of the sella turcica. N (Nasion): The junction of the frontal bone and nasal bones at the bridge of the nose.
A (Point A): A point on the deepest curve of the maxillary alveolar bone. B (Point B): A point on the deepest curve of the mandibular alveolar bone. The ANB angle is calculated as SNA - SNB, providing an assessment of the relationship between the upper and lower jaws. It is typically used to diagnose skeletal discrepancies, such as Class I, Class II, or Class III jaw relationships.
Measured: 6 months
ECOHIS
ECOHIS, or the Early Childhood Oral Health Impact Scale, is a questionnaire designed to assess the impact of oral health problems and dental treatments on the quality of life of young children and their families. It is specifically aimed at children aged 0 to 5 years and evaluates the broader effects of oral health issues beyond just clinical symptoms.
The ECOHIS is valuable in research and clinical practice as it helps to understand the broader impact of oral health issues, guiding treatment planning and interventions aimed at improving not only the clinical condition but also the overall well-being of young children and their families.
Measured: 6 months
Secondary outcomes (4)
SNB
SNB is an angle measurement used in orthodontics and cephalometrics to assess the position of the mandible (lower jaw) relative to the cranial base. It is measured using three reference points:
S (Sella): The center of the sella turcica, a cavity in the sphenoid bone that houses the pituitary gland.
N (Nasion): The point where the frontal bone and the nasal bones meet, located at the bridge of the nose.
B (Point B): A point on the deepest curvature of the mandibular alveolar process, which is the bone that holds the lower teeth.
The SNB angle helps determine whether the mandible is positioned normally, or if it is too far forward (protrusive) or too far back (retrusive) relative to the cranial base. A typical SNB value is around 80 degrees. Higher values indicate mandibular protrusion, while lower values suggest mandibular retrusion. This measurement is essential for diagnosing skeletal discrepancies and planning orthodontic treatments that address the alignment of the jaws.
Measured: 6 months
SNA
SNA is an angle measurement used in orthodontics and cephalometrics to assess the position of the maxilla (upper jaw) relative to the cranial base. It is measured by evaluating the angle between three points:
S (Sella): The center of the sella turcica, a cavity in the sphenoid bone that houses the pituitary gland.
N (Nasion): The point where the frontal bone and the nasal bones meet, located at the bridge of the nose.
A (Point A): A point on the deepest curvature of the maxillary alveolar process, which is the bone that holds the upper teeth.
The SNA angle helps determine whether the maxilla is positioned normally, or if it is too far forward (protrusive) or too far back (retrusive) relative to the cranial base. A typical SNA value is around 82 degrees. Higher values suggest maxillary protrusion, while lower values indicate maxillary retrusion. This measurement is crucial in diagnosing and planning treatments for orthodontic and skeletal alignment issues.
Measured: 6 months
U1SN
U1SN is an orthodontic cephalometric measurement that assesses the angulation of the upper front teeth (upper incisors) relative to the cranial base. It helps determine the inclination of the maxillary incisors and is measured as the angle between two lines:
U1 (Upper Incisor Line): A line that runs through the long axis of the upper central incisor.
SN (Sella-Nasion Line): A line that connects the Sella (S) point to the Nasion (N) point, representing the base of the skull.
The U1SN angle indicates the degree of forward or backward tilt of the upper incisors. Typical values range between 102 to 110 degrees.
Measured: 6 months
L1MP
L1MP is a cephalometric measurement used in orthodontics to assess the inclination of the lower front teeth (lower incisors) relative to the mandibular plane. It helps to determine the angulation of the lower incisors and is measured as the angle between two lines:
L1 (Lower Incisor Line): A line drawn through the long axis of the lower central incisor.
MP (Mandibular Plane): A line that typically runs from the Menton (the lowest point on the chin) to the Gonion (the angle of the jaw).
The L1MP angle indicates the degree of forward or backward tilt of the lower incisors. Normal values for this angle are usually around 90 to 95 degrees.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start2 Mar 2016
- Primary completion10 Aug 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HabitsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Xueqiang, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650241
- Sponsor's protocol ID
- QFELL-YJ-2016-66
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparative Study of Different Methods for Correcting Lower Lip Sucking Habits in Preschool Children
- ClinicalTrials.gov ID
- NCT06650241
- Acronym / sponsor ID
- QFELL-YJ-2016-66
- Conditions
- Oral Habits
- Keywords
- preschool children, Oral Health-Related Quality of Life (OHRQoL), Early Childhood Oral Health Impact Scale (ECOHIS),
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 21 Oct 2024 (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.
Comparison of the Effectiveness of Behavioral Therapy, Maxillary Lip Bumper Appliance, and Twin-Block Appliance in Correcting Lower Lip Sucking Habits in Children
Detailed description
Intervention Methods Behavioral Therapy Group: Children were rewarded with their favorite candy or toys as positive reinforcement when they refrained from sucking their lower lip. When they exhibited lip-sucking behavior, corresponding punishments were applied (e.g., being prohibited from watching cartoons for 1 hour or from playing with toys) as negative reinforcement. At night, bitter nail polish or substances with unpleasant smells were applied to the lower lip as aversive stimuli. Patients attended follow-up appointments monthly.
Lip Bumper Therapy Group: The treatment involved placing arrow-shaped clasps and interproximal hooks on the maxillary molars, with a double-curved labial bow positioned on the labial side of the upper anterior teeth. A lip bumper wire was soldered at the position of the maxillary central incisors. The lip bumper wire should reach the mandibular vestibular groove to support the lower lip without obstructing the natural labial adjustment of the lower anterior teeth. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments were conducted, during which the double-curved labial bow could be adjusted to retract the upper anterior teeth.
Modified Twin-Block Therapy Group: Initially, occlusal reconstruction was performed, with the combined forward movement of the mandible and vertical dimension being less than 10 mm. The standard criteria were an incisal edge-to-edge bite of the upper and lower anterior teeth, with the vertical opening in the posterior region exceeding the resting occlusal gap by 2-3 mm. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments included progressive grinding of the maxillary occlusal pads. If discrepancies in arch width occurred, expansion therapy was implemented.
Evaluation of Therapeutic Efficacy
All children were assessed for the following indicators after 6 months of treatment:
- Comparison of Lip-Sucking Habit Improvement: The outcome of lip-sucking habit correction was compared among the groups. Treatment was considered successful if the lip-sucking habit was completely corrected, malocclusion was improved, and parents were satisfied. It was considered unsuccessful if there was no significant improvement in the lip-sucking habit and parents were dissatisfied. Success rate = (Number of successful cases / Total number of cases) × 100%.
- Comparison of Oral Examination and Model Analysis Indicators:** Oral examinations and oral model preparation were conducted before treatment (T0) and one month after the end of treatment (T2). Changes in the overjet of the anterior teeth were measured using a vernier caliper.
- Comparison of Cephalometric Measurements:Lateral cephalometric radiographs were taken before treatment (T0) and one month after the end of treatment (T2). SNA, SNB, ANB, U1-SN, and L1-MP angles were measured using Dolphin software (Version 11.8, Dolphin Imaging and Management Solutions, CA, USA).
- Assessment of Oral Health-Related Quality of Life (OHRQoL) using the ECOHIS Questionnaire:The Chinese version of the Early Childhood Oral Health Impact Scale (ECOHIS) was used to assess the impact of lip-sucking habits and orthodontic treatment on children's OHRQoL. Parents completed the ECOHIS questionnaire before treatment (T0), after 1 month of treatment (T1), and 1 month after the end of treatment (T2). The questionnaire includes 13 items, covering the *Child Impact Section* (CIS) which assesses the impact on the child's symptoms, functions, psychology, and social interactions, as well as the *Family Impact Section* (FIS), which assesses the impact on parental distress and family function. Each item is rated on a scale of 0-5: never (0), hardly ever (1), occasionally (2), often (3), very often (4), don't know (5). The total ECOHIS score is calculated by summing the response codes from both CIS and FIS sections. The score ranges from 0 to 65, with higher scores indicating a greater negative impact on children's OHRQoL. The questionnaire was considered invalid if there were more than two "don't know" responses in the CIS or one in the FIS, and another child was selected for inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral therapy | Experimental | Other: Behavioral therapyBehavioral Therapy Group: Children were rewarded with their favorite candy or toys as positive reinforcement when they refrained from sucking their lower lip. When they exhibited lip-sucking behavior, corresponding punishments were applied (e.g., being prohibited from watching cartoons for 1 hour or from playing with toys) as negative reinforcement. At night, bitter nail polish or substances with unpleasant smells were applied to the lower lip as aversive stimuli. Patients attended follow-up appointments monthly. |
| Maxillary lip bumper appliance | Experimental | Other: Lip Bumper TherapyLip Bumper Therapy Group: The treatment involved placing arrow-shaped clasps and interproximal hooks on the maxillary molars, with a double-curved labial bow positioned on the labial side of the upper anterior teeth. A lip bumper wire was soldered at the position of the maxillary central incisors. The lip bumper wire should reach the mandibular vestibular groove to support the lower lip without obstructing the natural labial adjustment of the lower anterior teeth. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments were conducted, during which the double-curved labial bow could be adjusted to retract the upper anterior teeth. |
| Twin-block | Experimental | Other: Modified Twin-Block TherapyModified Twin-Block Therapy Group: Initially, occlusal reconstruction was performed, with the combined forward movement of the mandible and vertical dimension being less than 10 mm. The standard criteria were an incisal edge-to-edge bite of the upper and lower anterior teeth, with the vertical opening in the posterior region exceeding the resting occlusal gap by 2-3 mm. Patients were required to wear the appliance at all times except during meals and oral hygiene activities. Monthly follow-up appointments included progressive grinding of the maxillary occlusal pads. If discrepancies in arch width occurred, expansion therapy was implemented. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preschool children aged 3-6 years,
- Habit of lower lip sucking,
- No anterior crossbite or open bite,
- Missing no more than 2 incisors in a single jaw,
- No other systemic diseases,
Key exclusion criteria (4 listed)
- Prior orthodontic treatment;
- Tooth extraction;
- Mini-implant usage;
- Chronic rhinitis, tonsil hypertrophy and other upper airway diseases.
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 |
|---|---|---|
| Behavioral therapy | Other | Behavioral therapy |
| Lip Bumper Therapy | Other | Maxillary lip bumper appliance |
| Modified Twin-Block Therapy | Other | Twin-block |
Primary outcome
overjet
Time frame: 6 months
Overjet refers to the horizontal distance between the front edge of the upper front teeth (maxillary incisors) and the front edge of the lower front teeth (mandibular incisors). In a normal alignment, the upper front teeth slightly overlap the lower front teeth, but when this overlap is excessive, it results in a noticeable overjet. From a side view, overjet is measured as the horizontal distance between the upper and lower front teeth, typically in millimeters. A normal overjet is usually around 2-3 millimeters. If the distance is greater than this, it is considered abnormal. A large overjet can lead to issues with bite alignment, aesthetics, and function, such as difficulties with eating or speaking, and increased vulnerability to trauma.
ANB
Time frame: 6 months
ANB is an angle measurement used in orthodontics and cephalometrics to evaluate the relative position of the maxilla (upper jaw) to the mandible (lower jaw). It is derived from the difference between the SNA and SNB angles: S (Sella): The center of the sella turcica. N (Nasion): The junction of the frontal bone and nasal bones at the bridge of the nose. A (Point A): A point on the deepest curve of the maxillary alveolar bone. B (Point B): A point on the deepest curve of the mandibular alveolar bone. The ANB angle is calculated as SNA - SNB, providing an assessment of the relationship between the upper and lower jaws. It is typically used to diagnose skeletal discrepancies, such as Class I, Class II, or Class III jaw relationships.
ECOHIS
Time frame: 6 months
ECOHIS, or the Early Childhood Oral Health Impact Scale, is a questionnaire designed to assess the impact of oral health problems and dental treatments on the quality of life of young children and their families. It is specifically aimed at children aged 0 to 5 years and evaluates the broader effects of oral health issues beyond just clinical symptoms. The ECOHIS is valuable in research and clinical practice as it helps to understand the broader impact of oral health issues, guiding treatment planning and interventions aimed at improving not only the clinical condition but also the overall well-being of young children and their families.
4 secondary outcomes
SNB
Time frame: 6 months
SNA
Time frame: 6 months
U1SN
Time frame: 6 months
L1MP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral therapy, Lip Bumper Therapy and Modified Twin-Block Therapy in people with Oral Habits, run by Qingdao 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 4 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: finished, as of the sponsor's last update on 21 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overjet (time frame: 6 months). The study lists 3 primary outcomes in all. 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 21 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.