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

NCT ID: NCT06887660

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2025-06-10

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).

Conditions

Mouth Breathing

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Orthodontic patients

Orthodontic patients at their first dental visit

Orthodontic diagnosis

Intervention Type: OTHER

Initial Assessment Orthodontic residents assessed each patient based on their existing knowledge of speech therapy. They rated the necessity for a speech therapy consultation on a scale from 1 to 10, with 1 indicating "not necessary" and 10 indicating "absolutely necessary."

Protocol-Guided Assessment The same residents then reassessed the same patients using the Interdisciplinary Orofacial Evaluation Protocol. After this evaluation, they again rated the necessity for a speech therapy consultation using the same 1 to 10 scale.

Speech-therapist Evaluation Subsequently, a speech therapy specialist independently evaluated each patient using the same protocol and provided their rating for the necessity of a speech therapy consultation on the same scale.

Interventions

Orthodontic diagnosis

Initial Assessment Orthodontic residents assessed each patient based on their existing knowledge of speech therapy. They rated the necessity for a speech therapy consultation on a scale from 1 to 10, with 1 indicating "not necessary" and 10 indicating "absolutely necessary."

Protocol-Guided Assessment The same residents then reassessed the same patients using the Interdisciplinary Orofacial Evaluation Protocol. After this evaluation, they again rated the necessity for a speech therapy consultation using the same 1 to 10 scale.

Speech-therapist Evaluation Subsequently, a speech therapy specialist independently evaluated each patient using the same protocol and provided their rating for the necessity of a speech therapy consultation on the same scale.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2025-SPEECHTHERAPY

Identifier Type: -

Identifier Source: org_study_id