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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.
The questionnaires administered are as follows:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontisis | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functionnal test | Other | Administration of questionnaires, functional masticatory test, and saliva collection. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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) |