Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life (FI-PAROCROC)
2. juli 2026 oppdatert av: University Hospital, Clermont-Ferrand
The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis.
Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
The questionnaires administered are as follows:
- the EAT-10 (Eating Assessment Tool), used to assess swallowing disorders and the patient's perception of oropharyngeal dysphagia;
- the XI (Xerostomia Inventory), used to evaluate xerostomia;
- the GOHAI (General Oral Health Assessment Index), used to assess the impact of oral health status on patients' quality of life.
The functional test (masticatory performance "chewing gum" test) will be performed at each visit if applicable (T0, T1, T2) to evaluate the impact of periodontal treatment on masticatory function. The two-colour chewing gum test is a commonly used method for assessing masticatory mixing ability.
Saliva collection for salivary flow analysis will also be performed at each follow-up visit in order to evaluate the impact of periodontal treatment on salivary function.
Studietype
Intervensjonell
Registrering (Antatt)
44
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
Studiesteder
-
-
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Clermont-Ferrand, Frankrike
- CHU clermont-ferrand
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Ta kontakt med:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Hovedetterforsker:
- Thomas DOUILLARD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients treated at the university hospital and diagnosed with periodontitis
- Adult patients who have provided informed consent
- Patients enrolled in a social security system
- Patients who speak and understand French.
Exclusion Criteria:
- Minors
- Pregnant or breastfeeding patients
- Patients under legal protection or conservatorship
- Patients who refuse to participate in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Periodontisis
Patients diagnosed with periodontitis will receive standard non-surgical periodontal treatment as part of routine care.
Clinical and functional assessments will be performed at baseline (T0) and during follow-up visits (T1, T2) to evaluate changes in masticatory performance, salivary flow, and oral health-related quality of life.
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Administration of questionnaires, functional masticatory test, and saliva collection.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The patient's masticatory performance score
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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The patient's masticatory performance score, obtained from the masticatory performance test (two-color chewing gum test) (quantitative variable).
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Severity of periodontal disease assessed by stage.
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Periodontitis is defined according to two criteria: grade and stage. The latter is used to characterize the severity of periodontal involvement. The stage of periodontitis is determined according to a four-level classification system, ranging from Stage 1 (low) to Stage 4 (high). |
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Salivation
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Salivary flow is measured by collecting saliva at rest and after stimulation in mL/min.
Stimulated salivary flow is assessed after chewing paraffin for 1 minute.
The XI questionnaire (Xerostomia Inventory), proposed by Thomson et al. and validated in French, will also be administered (6,7).
The XI consists of 11 items.
Each item is scored on a scale of 1 to 5 to indicate how frequently the described situation occurs for the patient.
The scores for each item are added together to yield a total score ranging from 11 (no dry mouth) to 55 (extreme dry mouth).
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Swallowing
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Oropharyngeal dysphagia is assessed using the EAT-10 (Eating Assessment Tool) questionnaire, which has been validated in French.
The questionnaire comprises 10 items designed to assess swallowing disorders and the patient's perception of oropharyngeal dysphagia.
Each item is rated on a 5-point scale ranging from 0 (no difficulty) to 4 (severe difficulty), resulting in a total score ranging from 0 to 40.
A total score of 3 or higher indicates difficulty swallowing safely.
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Periodontitis grade (Chicago Classification)
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Grade of periodontitis according to the Chicago Classification.
Categorical (Grade A (low) to C (fast) or as defined by classification)
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Gingival recessions
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Measurement of gingival recession depth.
Unit of Measure : Millimeters (mm)
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Plaque Index
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Plaque accumulation assessed using a validated plaque index (specify full name of index). Unit of Measure: Score (range: specify minimum and maximum values of the scale) Interpretation: Higher scores indicate worse oral hygiene status. |
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Edentulism
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Presence or absence of edentulism.
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Bleeding on Probing (BOP)
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Percentage (%) of sites showing bleeding on probing.
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Pocket Depth
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Periodontal probing depth.
Unit of Measure: Millimeters (mm)
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Tooth Mobility
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Tooth mobility assessed using the Miller classification (Grade 0-3). Higher scores indicate greater mobility and worse periodontal condition. Unit of Measure: Millimeters (mm) |
Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Number of Posterior Functional Dental Units
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Count of posterior functional dental units.
Unit of Measure: Millimeters (mm)
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Oral quality of life
Tidsramme: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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The French version of the GOHAI (General Oral Health Assessment Index) questionnaire is used to assess the impact of oral health on participants' quality of life (10,11).
The GOHAI consists of 12 items divided into 3 subgroups: a group related to the functional domain (items 1, 2, 3, and 4), a group related to the psychosocial domain (items 6, 7, 9, 10, and 11), and a group related to pain and discomfort (items 5, 8, and 12).
Each question is scored on a scale of 1 to 5. The maximum score is 60.
The higher the score, the better the quality of life: a score of 57 to 60 corresponds to a satisfactory oral health-related quality of life; a score between 51 and 56 corresponds to an average quality of life; and a score below 50 corresponds to poor oral health.
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Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
11. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. mars 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RBHP 2026 DOUILLARD
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