Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- the DHEQ-fr questionnaire
研究概览
简要总结
Dentin hypersensitivity (DH) results in brief, sharp pain in response to a stimulus. It often seems to be underdiagnosed but also undertreated due to the lack of consensus on the topic. DH has been shown to affects patients' quality of life. The Dentine Hypersensitivity Experience Questionnaire (DHEQ)is developed and validated : which is questionnaire assessing specifically the impact of DH on patient's quality of life. The DHEQ aims to help diagnose DH and assess the impact and subjective experience of the patient in order to better meet their expectations in terms of treatment. A French version, the DHEQ-fr, has been proposed (translation-counter-translation process and pilot study); however, it has not yet been validated (psychometric tests, test-retest).
The main objective of the present study is to validate DHEQ-fr through a multicenter clinical study (three centers in France) in adult patients. The secondary objective is to compare the results of DHEQ-fr with those of the general oral health assessment index and oral health impact profil for the same patients. Patients are split between three DH groups (Schiff scores 1, 2 and 3) and a control group (non-DH). The overall sample size (all centers considered) for the DH group is 162 subjects divided into 54 subjects for each Schiff score (1 to 3; after cold air stimulation), with a control group of 54 subjects. A re-test will be performed, at 15 days, on a random sample of 60 subjects from the study population (in total: 15 non-DH subjects; 15 with a Schiff score of 1; 15 with a score of 2; 15 with a score of 3). The study of psychometric properties such as acceptability, internal consistency, reproducibility and internal structure validity will allow the validation of this French version of the DHEQ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are able to understand the study
排除标准
- •Teeth with other pathologies in addition to HD (carious lesions, cracked enamel, etc.);
- •Abutment teeth for fixed or removable dentures and crown teeth;
- •Teeth with restorations involving the inner third of the dentin and/or restorations involving the dentinary/root exposure area;
- •Patients who have been on or have undergone desensitizing therapy for HD in the past three months;
- •Patients who have received periodontal surgery within the last three months;
- •Patients with orthodontic devices who have interrupted orthodontic treatment in the last three months;
- •Pregnant or breastfeeding patients;
- •Patients under guardianship, curatorship, safeguard of justice
- •Patients deprived of liberty
- •Patients participating in any other clinical study.
研究组 & 干预措施
dentin hypersensitivity group
patients with at least one tooth with a diagnosis of dentin hypersensitivity (DH) with dentin exposure related to gum recession and/or erosive lesion or with a diagnosis of DH with a gingival margin flush with the amelocementary junction. In patients with multiple teeth with DH, the study will consider the most painful tooth according to the EVA score on the air jet test.
干预措施: GOHAI questionnaire (Other)
dentin hypersensitivity group
patients with at least one tooth with a diagnosis of dentin hypersensitivity (DH) with dentin exposure related to gum recession and/or erosive lesion or with a diagnosis of DH with a gingival margin flush with the amelocementary junction. In patients with multiple teeth with DH, the study will consider the most painful tooth according to the EVA score on the air jet test.
干预措施: Schiff Test (Diagnostic Test)
dentin hypersensitivity group
patients with at least one tooth with a diagnosis of dentin hypersensitivity (DH) with dentin exposure related to gum recession and/or erosive lesion or with a diagnosis of DH with a gingival margin flush with the amelocementary junction. In patients with multiple teeth with DH, the study will consider the most painful tooth according to the EVA score on the air jet test.
干预措施: OHIP questionnaire (Other)
dentin hypersensitivity group
patients with at least one tooth with a diagnosis of dentin hypersensitivity (DH) with dentin exposure related to gum recession and/or erosive lesion or with a diagnosis of DH with a gingival margin flush with the amelocementary junction. In patients with multiple teeth with DH, the study will consider the most painful tooth according to the EVA score on the air jet test.
干预措施: DHEQ fr questionnaire (Other)
control group
Control group: The group of patients without DH will consist of patients from the study centers who meet the inclusion criteria and agree to participate.
干预措施: Schiff Test (Diagnostic Test)
control group
Control group: The group of patients without DH will consist of patients from the study centers who meet the inclusion criteria and agree to participate.
干预措施: GOHAI questionnaire (Other)
control group
Control group: The group of patients without DH will consist of patients from the study centers who meet the inclusion criteria and agree to participate.
干预措施: OHIP questionnaire (Other)
control group
Control group: The group of patients without DH will consist of patients from the study centers who meet the inclusion criteria and agree to participate.
干预措施: DHEQ fr questionnaire (Other)
结局指标
主要结局
the DHEQ-fr questionnaire
时间窗: one year
The 50 items constituting the original questionnaire can be divided in the following sections : Items #1-6: description of the sensations related to the pathology Items #7-9: scoring, using a visual analogue scale (VAS), of the intensity, the bothersomeness and the tolerability related to DH Items #10-45: scoring, using a seven-point Likert scale, of the impact of DH on QoL. Five domains or impact subscales can be identified: functional restriction (five items), adaptation (12 items), social impact (five items), emotional impact (eight items) and identity (six items) Item #46: A global oral health rating, with responses on a five-point Likert scale (from "excellent" to "very poor") Items #47-50: The questionnaire also contains four items recording the impact of the sensations on life overall, with responses on a five-point Likert scale (from "not at all" to "very much")
次要结局
未报告次要终点