Mouth BreathingNCT06887660
Speech-language Skills of Orthodontic Residents Through the Use of the "Interdisciplinary Orofacial Examination Protocol for Children and Adolescents"
An observational study of Mouth Breathing, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Mouth Breathing
- What is being tested?
- Orthodontic diagnosis
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2025to 10 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients scheduled for orthodontic evaluation will be visited for the first time at the Unit.
Who may be able to join
- Patients at their first dental visit
- No previous orthodontic treatment.
Who cannot join
- Patients with history of orthodontic therapy
- Patients with history of speech therapy
- Patients presenting cranio-facial syndroms and malformations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
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
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.
Read the 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
- Being tested
- Orthodontic diagnosis
- Keywords
- Orthodontic diagnosis
- Medical subject headings
- Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic diagnosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic patients | Orthodontic patients at their first dental visit Receives: Other: Orthodontic diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 2 weeks
Secondary outcomes (15)
Profile
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.
Measured: Baseline and after 2 weeks
Respiration pattern
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.
Measured: Baseline and after 2 weeks
Nostril Patency During Forced Breathing
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.
Measured: Baseline and after 2 weeks
Lips at Rest
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.
Measured: Baseline and after 2 weeks
Vertical Malocclusion
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.
Measured: Baseline and after 2 weeks
Sagittal Malocclusion
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.
Measured: Baseline and after 2 weeks
Transverse Malocclusion
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.
Measured: Baseline and after 2 weeks
Overbite
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.
Measured: Baseline and after 2 weeks
Overjet
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.
Measured: Baseline and after 2 weeks
Dental Alignment
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.
Measured: Baseline and after 2 weeks
Tonsil Size
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.
Measured: Baseline and after 2 weeks
Lingual Mobility
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.
Measured: Baseline and after 2 weeks
Muscle effort during swallowing
It observes the perioral muscle activity during swallowing, noting absence of effort, slight effort, or excessive effort, which can indicate dysfunctional swallowing patterns.
Measured: Baseline and after 2 weeks
Tongue movement during swallowing
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.
Measured: Baseline and after 2 weeks
Speech articulation
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.
Measured: Baseline and after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start30 Mar 2025
- Primary completion4 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887660
- Sponsor's protocol ID
- 2025-SPEECHTHERAPY
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887660
- Acronym / sponsor ID
- 2025-SPEECHTHERAPY
- Conditions
- Mouth Breathing
- Keywords
- Orthodontic diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic patients | – | Other: Orthodontic diagnosisOrthodontic patients at their first dental visit |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients scheduled for orthodontic evaluation will be visited for the first time at the Unit.
Key inclusion criteria (2 listed)
- Patients at their first dental visit
- No previous orthodontic treatment.
Key exclusion criteria (3 listed)
- Patients with history of orthodontic therapy
- Patients with history of speech therapy
- Patients presenting cranio-facial syndroms and malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthodontic diagnosisInitial 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. | Other | Orthodontic patients |
Primary outcome
Change in Diagnostic score
Time frame: 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.
15 secondary outcomes
Profile
Time frame: Baseline and after 2 weeks
Respiration pattern
Time frame: Baseline and after 2 weeks
Nostril Patency During Forced Breathing
Time frame: Baseline and after 2 weeks
Lips at Rest
Time frame: Baseline and after 2 weeks
Vertical Malocclusion
Time frame: Baseline and after 2 weeks
Sagittal Malocclusion
Time frame: Baseline and after 2 weeks
Transverse Malocclusion
Time frame: Baseline and after 2 weeks
Overbite
Time frame: Baseline and after 2 weeks
Overjet
Time frame: Baseline and after 2 weeks
Dental Alignment
Time frame: Baseline and after 2 weeks
Tonsil Size
Time frame: Baseline and after 2 weeks
Lingual Mobility
Time frame: Baseline and after 2 weeks
Muscle effort during swallowing
Time frame: Baseline and after 2 weeks
Tongue movement during swallowing
Time frame: Baseline and after 2 weeks
Speech articulation
Time frame: Baseline and after 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
Related trials for Mouth Breathing
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth Breathing, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnostic score (time frame: Baseline and after 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.