Speech-language Skills of Orthodontic Residents Through the Use of the "Interdisciplinary Orofacial Examination Protocol for Children and Adolescents"

• Conditions: Mouth Breathing

• Registration Number: NCT06887660
• Lead Sponsor: University of Pavia

Brief Summary

This prospective cross-sectional study 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 prospective cross-sectional study 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).

Study Timeline

• Study First Submitted: 2025-03-09
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-20
• Study Start: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients at their first dental visit
• No previous orthodontic treatment.

Exclusion Criteria

• Patients with history of orthodontic therapy
• Patients with history of speech therapy
• Patients presenting cranio-facial syndroms and malformations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Diagnostic score	Baseline and after 2 weeks	Score from 0 to 10 of the speech-language treatment need indicated by the Orthodontic Resident and confirmed by the diagnosis of a calibrated speech-language therapist.

Secondary Outcome Measures

Name	Time	Method
Tongue movement during swallowing	Baseline and after 2 weeks	It assesses tongue positioning during swallowing by having the patient hold and swallow a sip of water while the examiner observes for normal movement, anterior tongue thrust, or tongue interposition, which can affect dental alignment.
Speech articulation	Baseline and after 2 weeks	It evaluates phoneme production by having the patient repeat specific Italian words (e.g., "tetto," "lalla," "ciuccio," "sasso," "stella," "ramarro," "zanzara"). Observations include adequate articulation, sound distortions, or omission of sounds, aiding in the identification of speech disorders.
Profile	Baseline and after 2 weeks	It evaluates the patient's facial profile to identify any deviations from normal alignment. Classifications include normal, slightly concave/convex, or severely concave/convex profiles.
Respiration pattern	Baseline and after 2 weeks	It assesses the patient's habitual breathing method, determining if it is nasal, mixed, or oral. This evaluation helps identify potential respiratory issues that may affect orofacial development.
Nostril Patency During Forced Breathing	Baseline and after 2 weeks	It examines the degree of nasal airway obstruction during forced inhalation. Grades range from 0 (both nostrils dilate) to 5 (bilateral total collapse), providing insight into nasal airflow efficiency.
Lips at Rest	Baseline and after 2 weeks	It observes the patient's lip posture to determine if a natural lip seal is present without effort, achieved with effort, or absent. This assessment is crucial for understanding lip function and potential impacts on oral health.
Vertical Malocclusion	Baseline and after 2 weeks	It evaluates the vertical relationship between the upper and lower dental arches in maximum intercuspation. Classifications include normal occlusion, mild deep/open bite, or severe deep/open bite, indicating vertical alignment issues.
Sagittal Malocclusion	Baseline and after 2 weeks	It assesses the anteroposterior relationship of the molars to classify occlusion as Class I (normal), moderate Class II/III, or complete Class II/III, identifying discrepancies in jaw alignment.
Transverse Malocclusion	Baseline and after 2 weeks	It evaluates the transverse relationship between the dental arches, identifying normal alignment, edge-to-edge bite, or complete crossbite, which can affect chewing efficiency and facial symmetry.
Overbite	Baseline and after 2 weeks	It measures the vertical overlap between the upper and lower incisors. A normal overbite ranges between 2 to 3 millimeters; deviations may be classified as slightly or severely increased/reduced, impacting esthetics and function.
Overjet	Baseline and after 2 weeks	It assesses the horizontal distance between the upper and lower incisors. A normal overjet is 2 to 3 millimeters; variations can be slightly or severely increased/reduced, influencing speech and biting.
Dental Alignment	Baseline and after 2 weeks	It observes for crowding or spacing (diastemas) in the dental arches. Classifications include normal alignment, mild crowding/spacing, or severe crowding/spacing, which can affect oral hygiene and occlusion.
Tonsil Size	Baseline and after 2 weeks	It assesses the degree of tonsillar hypertrophy, ranging from Grade 0 (tonsillectomy) to Grade 5 (tonsils occupying more than 75% of the oropharynx), which can influence breathing and swallowing functions.
Lingual Mobility	Baseline and after 2 weeks	It evaluates tongue mobility by asking the patient to touch the palate with the tongue tip. Grades range from 0 (post-frenulectomy) to 5 (tongue tip does not reach the lower incisor edge), identifying potential restrictions like tongue-tie.
Muscle effort during swallowing	Baseline and after 2 weeks	It observes the perioral muscle activity during swallowing, noting absence of effort, slight effort, or excessive effort, which can indicate dysfunctional swallowing patterns.

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy