A Clinical Comparative Study of Different Methods for Correcting Lower Lip Sucking Habits in Preschool Children

NCT06650241 | Completed

• 1 other identifier: QFELL-YJ-2016-66
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of the Effectiveness of Behavioral Therapy, Maxillary Lip Bumper Appliance, and Twin-Block Appliance in Correcting Lower Lip Sucking Habits in Children

Conditions

Oral Habits

Keywords

preschool children, Oral Health-Related Quality of Life (OHRQoL), Early Childhood Oral Health Impact Scale (ECOHIS),

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months

Secondary Outcomes (4)

• SNB

  6 months

• SNA

  6 months

• U1SN

  6 months

• L1MP

  6 months

Study Arms (3)

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.

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.

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.

Other: Modified Twin-Block Therapy

Interventions

Behavioral therapy OTHER

Behavioral therapy

Lip Bumper Therapy OTHER

Maxillary lip bumper appliance

Modified Twin-Block Therapy OTHER

Twin-block

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Prior orthodontic treatment;
• Tooth extraction;
• Mini-implant usage;
• Chronic rhinitis, tonsil hypertrophy and other upper airway diseases.

Sponsors & Collaborators

• Qingdao University: lead

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: March 2, 2016
• Primary Completion: August 10, 2024
• Study Completion: September 9, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share