Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life (FI-PAROCROC)
2 juli 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
44
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
Studieorter
-
-
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Clermont-Ferrand, Frankrike
- CHU clermont-ferrand
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Kontakt:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Huvudutredare:
- Thomas DOUILLARD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The patient's masticatory performance score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Severity of periodontal disease assessed by stage.
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 september 2028
Studieregistreringsdatum
Först inskickad
1 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
16 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2026
Senast verifierad
1 mars 2026
Mer information
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