Atypical SwallowingNCT07534306
Impact of Atypical Swallowing on Periodontal Health in Adults
An observational study of Atypical Swallowing and Periodontal Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This study aims to evaluate the prevalence of atypical (dysfunctional) swallowing in an adult population affected by periodontitis. The research investigates the correlation between dysfunctional swallowing patterns - characterized by abnormal tongue thrust-and clinical oral manifestations such as dental mobility and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atypical Swallowing, Periodontal Disease
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 1 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Periodontal patients belonging to the dentistry department of the Policlinico Umberto I
Who may be able to join
- age over 18
- periodontal patients
- informed consent
Who cannot join
- age under 18
- inability to understand and want
- the language barrier such as to prevent full understanding of the questionnaire
- any problems with surgical resection of the tongue
- the lack of dental elements in the frontal sectors (in particular 2° and 5° sextant) or the presence of unrehabilitated edentulous saddles in those areas
- absence of radiographic documentation
- non-periodontal patients
- failure to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Investigation of Atypical Swallowing in the Adult Population: Assessment of Clinical Signs
This study aims to evaluate the prevalence of atypical (dysfunctional) swallowing in an adult population affected by periodontitis. The research investigates the correlation between dysfunctional swallowing patterns - characterized by abnormal tongue thrust-and clinical oral manifestations such as dental mobility and the worsening of periodontal conditions. By analyzing data collected through patient questionnaires and clinical evaluations, the study seeks to highlight how incorrect lingual posture and pressure can negatively influence the integrity of the tooth-supporting tissues in adults.
Read the detailed description
The study aims to investigate whether atypical swallowing acts as a "secondary occlusal trauma," which exacerbates periodontal damage in tissues already compromised by inflammation.
Data Collection: Patients are screened using a specific questionnaire to detect "vicious habits" (e.g., thumb sucking, lip biting) and respiratory issues (e.g., mouth breathing due to deviated septum or adenoid hypertrophy) that contribute to incorrect lingual posture.
Clinical Indicators: The study monitors several oral manifestations associated with tongue thrust, including the formation of an anterior open bite, diastemas, localized calculus accumulation, and gingival recessions.Clinical Implications: The research explores how the lack of physiological palatal expansion and low tongue posture can lead to a narrow "ogival" palate and subsequent occlusal instability. The results are intended to validate the importance of a multidisciplinary diagnostic approach - involving dental hygienists, orthodontists, and speech therapists- to improve the long-term prognosis of periodontal therapy and prevent orthodontic relapses.
- Conditions
- Atypical Swallowing, Periodontal Disease
- Keywords
- atypical swallowing, periodontal disease, secondary occlusal trauma
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with periodontal disease | Patients with atyipical swallowing and periodontal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Atypical Swallowing in Adult Periodontal Patients
The primary goal is to determine the frequency of dysfunctional swallowing patterns within a selected sample of adults diagnosed with periodontitis. This is assessed through a standardized clinical evaluation of tongue posture (at rest and during deglutition) and the administration of a structured diagnostic questionnaire. The outcome is expressed as the percentage of the study population exhibiting atypical swallowing compared to physiological swallowing.
Measured: Baseline (at the time of the single clinical examination).
Secondary outcomes (1)
Presence of Associated clinical alterations
Measurement of the prevalence of specific dental-skeletal signs associated with dysfunctional swallowing in the adult sample, such as anterior open bite, ogival (narrow) palate, and the presence of diastemas or localized calculus accumulation in the lower incisor area.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Nov 2024
- Primary completion1 Sep 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atypical SwallowingStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534306
- Sponsor's protocol ID
- 4/2024
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
SA Miremadi, AA Khoshkhounejad, E. Mahdavi. La prevalenza della spinta linguale nei pazienti con malattia parodontale. Front Dent. 1;2(2):50-53.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Investigation of Atypical Swallowing in the Adult Population: Assessment of Clinical Signs
- ClinicalTrials.gov ID
- NCT07534306
- Acronym / sponsor ID
- 4/2024
- Conditions
- Atypical Swallowing, Periodontal Disease
- Keywords
- atypical swallowing, periodontal disease, secondary occlusal trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Apr 2026 (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 study aims to evaluate the prevalence of atypical (dysfunctional) swallowing in an adult population affected by periodontitis. The research investigates the correlation between dysfunctional swallowing patterns - characterized by abnormal tongue thrust-and clinical oral manifestations such as dental mobility and the worsening of periodontal conditions. By analyzing data collected through patient questionnaires and clinical evaluations, the study seeks to highlight how incorrect lingual posture and pressure can negatively influence the integrity of the tooth-supporting tissues in adults.
Detailed description
The study aims to investigate whether atypical swallowing acts as a "secondary occlusal trauma," which exacerbates periodontal damage in tissues already compromised by inflammation.
Data Collection: Patients are screened using a specific questionnaire to detect "vicious habits" (e.g., thumb sucking, lip biting) and respiratory issues (e.g., mouth breathing due to deviated septum or adenoid hypertrophy) that contribute to incorrect lingual posture.
Clinical Indicators: The study monitors several oral manifestations associated with tongue thrust, including the formation of an anterior open bite, diastemas, localized calculus accumulation, and gingival recessions.Clinical Implications: The research explores how the lack of physiological palatal expansion and low tongue posture can lead to a narrow "ogival" palate and subsequent occlusal instability. The results are intended to validate the importance of a multidisciplinary diagnostic approach - involving dental hygienists, orthodontists, and speech therapists- to improve the long-term prognosis of periodontal therapy and prevent orthodontic relapses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with periodontal disease | – | –Patients with atyipical swallowing and periodontal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontal patients belonging to the dentistry department of the Policlinico Umberto I
Key inclusion criteria (3 listed)
- age over 18
- periodontal patients
- informed consent
Key exclusion criteria (8 listed)
- age under 18
- inability to understand and want
- the language barrier such as to prevent full understanding of the questionnaire
- any problems with surgical resection of the tongue
- the lack of dental elements in the frontal sectors (in particular 2° and 5° sextant) or the presence of unrehabilitated edentulous saddles in those areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Atypical Swallowing in Adult Periodontal Patients
Time frame: Baseline (at the time of the single clinical examination).
The primary goal is to determine the frequency of dysfunctional swallowing patterns within a selected sample of adults diagnosed with periodontitis. This is assessed through a standardized clinical evaluation of tongue posture (at rest and during deglutition) and the administration of a structured diagnostic questionnaire. The outcome is expressed as the percentage of the study population exhibiting atypical swallowing compared to physiological swallowing.
1 secondary outcome
Presence of Associated clinical alterations
Time frame: baseline
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 20 Apr 2026.
- BackgroundSA Miremadi, AA Khoshkhounejad, E. Mahdavi. La prevalenza della spinta linguale nei pazienti con malattia parodontale. Front Dent. 1;2(2):50-53.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atypical Swallowing and Periodontal Disease, run by University of Roma La Sapienza 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 3 inclusion and 8 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 20 Apr 2026. 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?
Prevalence of Atypical Swallowing in Adult Periodontal Patients (time frame: Baseline (at the time of the single clinical examination).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534306, which also lists 1 linked publication.
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 20 Apr 2026.