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Not yet recruiting NCT07651579

Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life

No phase Interventional Periodontitis Periodontal Diseases Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functionnal test.
Who it may be relevant to
Registry conditions: Periodontitis, Periodontal Diseases, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Functionnal test
    Administration of questionnaires, functional masticatory test, and saliva collection.

Primary outcome measures

  • The patient's masticatory performance score [Time frame: 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 (12)
  • Severity of periodontal disease assessed by stage. [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07651579 · RBHP 2026 DOUILLARD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗