Clinical trial NCT06466200: Validation of a French Version of the DHEQ
Official title: Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dentin Hypersensitivity
Quality of Life
Keywords: Oral health
Dentin Hypersensitivity
Quality of Life
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During their management in the 3 study centers, if the diagnosis of dentin hypersensitivity (DH) is made, a patient may be offered to participate in the study. The group of patients without DH (control group) will consist of patients who meet the inclusion and non-inclusion criteria and who agree to participate.

Participants will answer the questionnaires on their first visit. A second visit will be organized for the 60 patients randomly selected for a re-test at 15 days.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients who are able to understand the study

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the DHEQ-fr questionnaire
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lyon
country: France
facility: Centre de soins bucco-dentaires
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Sophie Domejean
role: PRINCIPAL_INVESTIGATOR
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