Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650241
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
A Clinical Comparative Study of Different Methods for Correcting Lower Lip Sucking Habits in Preschool Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Comparative Study of Different Methods for Correcting Lower Lip Sucking Habits in Preschool Children
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
1 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
2 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
3 Comparison of Cephalometric MeasurementsLateral 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 118 Dolphin Imaging and Management Solutions CA USA
4 Assessment of Oral Health-Related Quality of Life OHRQoL using the ECOHIS QuestionnaireThe 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 childrens 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 childs 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 dont 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 childrens OHRQoL The questionnaire was considered invalid if there were more than two dont know responses in the CIS or one in the FIS and another child was selected for inclusion
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
1 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
2 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
3 Comparison of Cephalometric MeasurementsLateral 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 118 Dolphin Imaging and Management Solutions CA USA
4 Assessment of Oral Health-Related Quality of Life OHRQoL using the ECOHIS QuestionnaireThe 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 childrens 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 childs 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 dont 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 childrens OHRQoL The questionnaire was considered invalid if there were more than two dont know responses in the CIS or one in the FIS and another child was selected for inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None