Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life (FI-PAROCROC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Periodontitis; Periodontal Diseases
• Intervention / Treatment: Other: Functionnal test

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 0473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU clermont-ferrand
    • Contact: Lise Laclautre; Phone Number: 0473754963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Thomas DOUILLARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Functionnal test; Administration of questionnaires, functional masticatory test, and saliva collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The patient's masticatory performance score	The patient's masticatory performance score, obtained from the masticatory performance test (two-color chewing gum test) (quantitative variable).	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of periodontal disease assessed by stage.	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)
Salivation	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).	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)
Swallowing	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.	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)
Periodontitis grade (Chicago Classification)	Grade of periodontitis according to the Chicago Classification. Categorical (Grade A (low) to C (fast) or as defined by classification)	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)
Gingival recessions	Measurement of gingival recession depth. 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)
Plaque Index	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)
Edentulism	Presence or absence of edentulism.	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)
Bleeding on Probing (BOP)	Percentage (%) of sites showing bleeding on probing.	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)
Pocket Depth	Periodontal probing depth. 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)
Tooth Mobility	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)
Number of Posterior Functional Dental Units	Count of posterior functional dental units. 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)
Oral quality of life	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.	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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: RBHP 2026 DOUILLARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No