Validation of a French Version of the DHEQ

NCT06466200 | Completed

• 2 other identifiers: RBHP 2024 DOMEJEAN2024-A00861-66
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

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.

Conditions

Dentin Hypersensitivity; Quality of Life

Keywords

Oral health; Dentin Hypersensitivity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• the DHEQ-fr questionnaire

  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")

  one year

Study Arms (2)

dentin hypersensitivity group

OTHER

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.

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

control group

OTHER

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.

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

Interventions

DHEQ fr questionnaire OTHER

dentin hypersensitivity and oral health-related quality of life assessment by questionnaire

control group; dentin hypersensitivity group

Schiff Test DIAGNOSTIC_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.

control group; dentin hypersensitivity group

GOHAI questionnaire OTHER

Oral health-related quality of life assessment by questionnaire

control group; dentin hypersensitivity group

OHIP questionnaire OTHER

Oral health-related quality of life assessment by questionnaire

control group; dentin hypersensitivity group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are able to understand the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, 33040, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Centre de soins bucco-dentaires

Lyon, 69000, France

Location

Related Publications (23)

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• He SL, Wang JH. Reliability and validity of the Chinese version of the short form of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15). Qual Life Res. 2015 Jun;24(6):1465-9. doi: 10.1007/s11136-014-0856-8. Epub 2014 Nov 9.

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MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sophie Domejean

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 20, 2024
• Study Start: June 25, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)