An interventional study of Behavioral therapy and Lip Bumper Therapy in Oral Habits, sponsored by Qingdao University. Completed. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Qingdao University · Not applicable, Interventional, and Treatment
Comparison of the Effectiveness of Behavioral Therapy, Maxillary Lip Bumper Appliance, and Twin-Block Appliance in Correcting Lower Lip Sucking Habits in Children
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:
Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
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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.
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.
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.
Other: Behavioral therapy
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.
Other: Lip Bumper Therapy
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.
Other: Modified Twin-Block Therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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Plan to share: No
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Ran from Mar 2016 to primary completion in Aug 2024, 101 months.
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