Trials / Completed
CompletedNCT06466200
Validation of a French Version of the DHEQ
Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Schiff Test | Use of an air syringe positioned perpendicular to the tooth surface at a distance of 1 cm. A scale to determine the intensity of DH was created, with the SASS (Shiff Analog Sensitivity Scale) ranging from 0 to 3 (0 being the absence of pain felt by the patient and 3 being pain considered intolerable). If the pain is greater than 1 then the patient is considered hypersensitive. |
| OTHER | GOHAI questionnaire | Oral health-related quality of life assessment by questionnaire |
| OTHER | OHIP questionnaire | Oral health-related quality of life assessment by questionnaire |
| OTHER | DHEQ fr questionnaire | dentin hypersensitivity and oral health-related quality of life assessment by questionnaire |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2025-11-07
- Completion
- 2025-11-07
- First posted
- 2024-06-20
- Last updated
- 2026-03-12
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06466200. Inclusion in this directory is not an endorsement.