Validation of a French Version of the DHEQ (DHEQ-VALID)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Quality of Life; Dentin Hypersensitivity

Treatments: Other: DHEQ fr questionnaire; Other: OHIP questionnaire; Other: GOHAI questionnaire; Diagnostic Test: Schiff Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06466200

RBHP 2024 DOMEJEAN

2024-A00861-66 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

dentin hypersensitivity group

Other group

Description:

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.

Treatment:

Other: GOHAI questionnaire

Diagnostic Test: Schiff Test

Other: OHIP questionnaire

Other: DHEQ fr questionnaire

control group

Other group

Description:

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.

Treatment:

Other: GOHAI questionnaire

Diagnostic Test: Schiff Test

Other: OHIP questionnaire

Other: DHEQ fr questionnaire