Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life (FI-PAROCROC)
2026年7月2日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lise Laclautre
- 电话号码：0473754963
- 邮箱：promo_interne_drci@chu-clermontferrand.fr
学习地点
-
-
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Clermont-Ferrand、法国
- CHU clermont-ferrand
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接触：
- Lise Laclautre
- 电话号码：0473754963
- 邮箱：promo_interne_drci@chu-clermontferrand.fr
-
首席研究员：
- Thomas DOUILLARD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The patient's masticatory performance score
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of periodontal disease assessed by stage.
大体时间：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). |
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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年7月2日
最后验证
2026年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.