Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The patient's masticatory performance score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant or breastfeeding patients
- •Patients under legal protection or conservatorship
- •Patients who refuse to participate in the study
研究组 & 干预措施
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.
干预措施: Functionnal test (Other)
结局指标
主要结局
The patient's masticatory performance score
时间窗: 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).
次要结局
- Severity of periodontal disease assessed by stage.(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(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(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)(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(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(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(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)(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(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(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(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(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))