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NCT Number: NCT07651579

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Lise Laclautre

CONTACT

[email protected]

0473754963

Thomas DOUILLARD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functionnal test

Other

Administration of questionnaires, functional masticatory test, and saliva collection.

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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).

  3. 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)

    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.

  4. 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)

    Grade of periodontitis according to the Chicago Classification. Categorical (Grade A (low) to C (fast) or as defined by classification)

  5. 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)

    Measurement of gingival recession depth. Unit of Measure : Millimeters (mm)

  6. 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)

    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.

  7. 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)

    Presence or absence of edentulism.

  8. 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)

    Percentage (%) of sites showing bleeding on probing.

  9. 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)

    Periodontal probing depth. Unit of Measure: Millimeters (mm)

  10. 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)

    Tooth mobility assessed using the Miller classification (Grade 0-3). Higher scores indicate greater mobility and worse periodontal condition.

    Unit of Measure: Millimeters (mm)

  11. 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)

    Count of posterior functional dental units. Unit of Measure: Millimeters (mm)

  12. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: FI-PAROCROC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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