- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534306
Impact of Atypical Swallowing on Periodontal Health in Adults
Epidemiological Investigation of Atypical Swallowing in the Adult Population: Assessment of Clinical Signs
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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RM
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Roma, RM, Italy, 00161
- Sapienza università di Roma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age over 18
- periodontal patients
- informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with periodontal disease
Patients with atyipical swallowing and periodontal disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of Atypical Swallowing in Adult Periodontal Patients
Time Frame: Baseline (at the time of the single clinical examination).
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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.
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Baseline (at the time of the single clinical examination).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presence of Associated clinical alterations
Time Frame: baseline
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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.
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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