Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT06887660
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2025-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech-language Skills of Orthodontic Residents Through the Use of the "Interdisciplinary Orofacial Examination Protocol for Children and Adolescents"
Sponsor:
University of Pavia
Organization:
Study Overview
Official Title:
Speech-language Skills of Orthodontic Residents Through the Use of the "Interdisciplinary Orofacial Examination Protocol for Children and Adolescents": Single-group Pre-post Study With External Validation
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single-group pre-post study with external validation will be conducted on 29 orthodontic residents at the University of Pavia to assess their ability to recognize orofacial myofunctional disorders (OMD) before and after using an Interdisciplinary Orofacial Examination Protocol for Children and Adolescents. Even though this was the main purpose, the study investigated also the effectiveness of the Protocol in guiding the diagnosis of OMD.
Detailed Description:
This single-group pre-post study with external validation aims to investigate the knowledge of orthodontic residents in the diagnosis of OMD. The study will be conducted on a sample of 29 residents enrolled at the Postgraduate Program of Orthodontics of the University of Pavia. Parents/legal guardians will be asked to sign the informed consent for the participations of patients in the study. The study cohort will be constituted of orthodontic patients aged 6-18 that will be visited for their first time at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia.
The first part of the study will involve the administration to the parents of the patients an anamnestic form aimed to investigate the patient's general health status, potential oral habits, respiratory condition, and any speech disorders. The responses to the questionnaire will be categorized as "Yes," "No," or "Sometimes.". Following the completion of the questionnaire, orthodontic residents will be asked to evaluate the patients based on their current knowledge of speech therapy and to determine the necessity of a trained speech therapy consultation. They will record their assessments on a dedicated form, rating the necessity on a scale from 1 to 10, where 1 indicates no necessity and 10 indicates absolute necessity (T0). After this initial assessment, the same residents will reassess each patient using the Interdisciplinary Orofacial Examination Protocol as a guideline (T1). Once they will complete this second evaluation, they will be required to rate the necessity for speech therapy consultation on the same 1 to 10 scale. In the final step (T2), each patient will be evaluated after 2 weeks by a specialist speech therapist using the same protocol. The speech therapist will independently assign a final score from 1 to 10, indicating the necessity for further speech therapy evaluation. After all evaluations will be completed, the responses will be codified into a scoring system, allowing to quantify the severity of each dysfunction. The Interdisciplinary Protocol used in this study comprises 15 items designed to assess patients from orthodontic, myofunctional, and phonatory perspectives.
These includes the evaluation of facial profile, breathing pattern, nasal airway function, lip seal at rest, and different types of malocclusions, such as vertical, sagittal, and transverse.
The protocol also measures overbite, overjet, and dental alignment, along with tonsil hypertrophy, tongue mobility, swallowing function, and articulation of speech sounds.
Data will be statistically analysed with data normality assessment and appropriate parametric or non-parametric test (significance threshold: p\<0.05).
The first part of the study will involve the administration to the parents of the patients an anamnestic form aimed to investigate the patient's general health status, potential oral habits, respiratory condition, and any speech disorders. The responses to the questionnaire will be categorized as "Yes," "No," or "Sometimes.". Following the completion of the questionnaire, orthodontic residents will be asked to evaluate the patients based on their current knowledge of speech therapy and to determine the necessity of a trained speech therapy consultation. They will record their assessments on a dedicated form, rating the necessity on a scale from 1 to 10, where 1 indicates no necessity and 10 indicates absolute necessity (T0). After this initial assessment, the same residents will reassess each patient using the Interdisciplinary Orofacial Examination Protocol as a guideline (T1). Once they will complete this second evaluation, they will be required to rate the necessity for speech therapy consultation on the same 1 to 10 scale. In the final step (T2), each patient will be evaluated after 2 weeks by a specialist speech therapist using the same protocol. The speech therapist will independently assign a final score from 1 to 10, indicating the necessity for further speech therapy evaluation. After all evaluations will be completed, the responses will be codified into a scoring system, allowing to quantify the severity of each dysfunction. The Interdisciplinary Protocol used in this study comprises 15 items designed to assess patients from orthodontic, myofunctional, and phonatory perspectives.
These includes the evaluation of facial profile, breathing pattern, nasal airway function, lip seal at rest, and different types of malocclusions, such as vertical, sagittal, and transverse.
The protocol also measures overbite, overjet, and dental alignment, along with tonsil hypertrophy, tongue mobility, swallowing function, and articulation of speech sounds.
Data will be statistically analysed with data normality assessment and appropriate parametric or non-parametric test (significance threshold: p\<0.05).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: