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

NCT06887660 | Completed

• 1 other identifier: 2025-SPEECHTHERAPY
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Breathing

Keywords

Orthodontic diagnosis

Outcome Measures

Primary Outcomes (1)

• Change in Diagnostic score

  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.

  Baseline and after 2 weeks

Secondary Outcomes (15)

• Profile

  Baseline and after 2 weeks

• Respiration pattern

  Baseline and after 2 weeks

• Nostril Patency During Forced Breathing

  Baseline and after 2 weeks

• Lips at Rest

  Baseline and after 2 weeks

• Vertical Malocclusion

  Baseline and after 2 weeks

Study Arms (1)

Orthodontic patients

Orthodontic patients at their first dental visit

Other: Orthodontic diagnosis

Interventions

Orthodontic diagnosis 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.

Orthodontic patients

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for orthodontic evaluation will be visited for the first time at the Unit.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Mouth Breathing

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: March 30, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 10, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)