Dentin HypersensitivityDHEQ-VALIDNCT06466200
Validation of a French Version of the DHEQ
A study testing Schiff Test, GOHAI questionnaire and OHIP questionnaire in people with Dentin Hypersensitivity and Quality of Life, run by University Hospital, Clermont-Ferrand at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Quality of Life
- What is being tested?
- Schiff Test, GOHAI questionnaire and OHIP questionnaire
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jun 2024to 7 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are able to understand the study
Who cannot join
- 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;
Show all 10Show fewer
- Pregnant or breastfeeding patients;
- Patients under guardianship, curatorship, safeguard of justice
- Patients deprived of liberty
- Patients participating in any other clinical study.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux
Bordeaux, 33040
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Centre de soins bucco-dentaires
Lyon, 69000
About this study
Official title: Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
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
- Being tested
- Schiff Test, GOHAI questionnaire, OHIP questionnaire, DHEQ fr questionnaire
- Keywords
- Oral health, Dentin Hypersensitivity, Quality of Life
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schiff TestDiagnostic 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.
GOHAI questionnaireOther
Oral health-related quality of life assessment by questionnaire
OHIP questionnaireOther
Oral health-related quality of life assessment by questionnaire
DHEQ fr questionnaireOther
dentin hypersensitivity and oral health-related quality of life assessment by questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Schiff Test; Other: GOHAI questionnaire; Other: OHIP questionnaire; Other: DHEQ fr questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start25 Jun 2024
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Domejean, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466200
- Sponsor's protocol ID
- RBHP 2024 DOMEJEAN
- Other IDs
- 2024-A00861-66
- Acronym
- DHEQ-VALID
- Status last verified
- Mar 2026
- First submitted
- 11 Jun 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
PubMed 12662460West NX, Sanz M, Lussi A, Bartlett D, Bouchard P, Bourgeois D. Prevalence of dentine hypersensitivity and study of associated factors: a European population-based cross-sectional study. J Dent. 2013 Oct;41(10):841-51. doi: 10.1016/j.jdent.2013.07.017. Epub 2013 Aug 1.
PubMed 23911597Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.
PubMed 30639724Martinez-Ricarte J, Faus-Matoses V, Faus-Llacer VJ, Flichy-Fernandez AJ, Mateos-Moreno B. Dentinal sensitivity: concept and methodology for its objective evaluation. Med Oral Patol Oral Cir Bucal. 2008 Mar 1;13(3):E201-6.
PubMed 18305444Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.
PubMed 9402502Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
PubMed 8534380Bekes K, John MT, Schaller HG, Hirsch C. Oral health-related quality of life in patients seeking care for dentin hypersensitivity. J Oral Rehabil. 2009 Jan;36(1):45-51. doi: 10.1111/j.1365-2842.2008.01901.x.
PubMed 19207369Atchison KA, Dolan TA. Development of the Geriatric Oral Health Assessment Index. J Dent Educ. 1990 Nov;54(11):680-7.
PubMed 2229624Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PubMed 8193981Wong AH, Cheung CS, McGrath C. Developing a short form of Oral Health Impact Profile (OHIP) for dental aesthetics: OHIP-aesthetic. Community Dent Oral Epidemiol. 2007 Feb;35(1):64-72. doi: 10.1111/j.1600-0528.2007.00330.x.
PubMed 17244139McGrath C, Wong AH, Lo EC, Cheung CS. The sensitivity and responsiveness of an oral health related quality of life measure to tooth whitening. J Dent. 2005 Sep;33(8):697-702. doi: 10.1016/j.jdent.2005.01.012. Epub 2005 Mar 19.
PubMed 16139701Boiko OV, Baker SR, Gibson BJ, Locker D, Sufi F, Barlow AP, Robinson PG. Construction and validation of the quality of life measure for dentine hypersensitivity (DHEQ). J Clin Periodontol. 2010 Nov;37(11):973-80. doi: 10.1111/j.1600-051X.2010.01618.x. Epub 2010 Sep 22.
PubMed 20860720Machuca C, Baker SR, Sufi F, Mason S, Barlow A, Robinson PG. Derivation of a short form of the Dentine Hypersensitivity Experience Questionnaire. J Clin Periodontol. 2014 Jan;41(1):46-51. doi: 10.1111/jcpe.12175. Epub 2013 Nov 19.
PubMed 24117603He SL, Wang JH, Wang MH. Development of the Chinese version of the Dentine Hypersensitivity Experience Questionnaire. Eur J Oral Sci. 2012 Jun;120(3):218-23. doi: 10.1111/j.1600-0722.2012.00962.x.
PubMed 22607338He 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.
PubMed 25381644
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06466200
- Acronym / sponsor ID
- DHEQ-VALID / RBHP 2024 DOMEJEAN
- Conditions
- Dentin Hypersensitivity, Quality of Life
- Keywords
- Oral health, Dentin Hypersensitivity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| dentin hypersensitivity group | Other | Diagnostic Test: Schiff Test, Other: GOHAI questionnaire, Other: OHIP questionnaire, Other: DHEQ fr questionnairepatients 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. |
| control group | Other | Diagnostic Test: Schiff Test, Other: GOHAI questionnaire, Other: OHIP questionnaire, Other: DHEQ fr questionnaireControl group: The group of patients without DH will consist of patients from the study centers who meet the inclusion criteria and agree to participate. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are able to understand the study
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schiff TestUse 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. | Diagnostic test | control group, dentin hypersensitivity group |
| GOHAI questionnaireOral health-related quality of life assessment by questionnaire | Other | control group, dentin hypersensitivity group |
| OHIP questionnaireOral health-related quality of life assessment by questionnaire | Other | control group, dentin hypersensitivity group |
| DHEQ fr questionnairedentin hypersensitivity and oral health-related quality of life assessment by questionnaire | Other | control group, dentin hypersensitivity group |
Primary outcome
the DHEQ-fr questionnaire
Time frame: 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")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 12662460Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
- Background: PubMed 23911597West NX, Sanz M, Lussi A, Bartlett D, Bouchard P, Bourgeois D. Prevalence of dentine hypersensitivity and study of associated factors: a European population-based cross-sectional study. J Dent. 2013 Oct;41(10):841-51. doi: 10.1016/j.jdent.2013.07.017. Epub 2013 Aug 1.
- Background: PubMed 30639724Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.
- Background: PubMed 18305444Martinez-Ricarte J, Faus-Matoses V, Faus-Llacer VJ, Flichy-Fernandez AJ, Mateos-Moreno B. Dentinal sensitivity: concept and methodology for its objective evaluation. Med Oral Patol Oral Cir Bucal. 2008 Mar 1;13(3):E201-6.
- Background: PubMed 9402502Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.
- Background: PubMed 8534380Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
- Background: PubMed 19207369Bekes K, John MT, Schaller HG, Hirsch C. Oral health-related quality of life in patients seeking care for dentin hypersensitivity. J Oral Rehabil. 2009 Jan;36(1):45-51. doi: 10.1111/j.1365-2842.2008.01901.x.
- Background: PubMed 2229624Atchison KA, Dolan TA. Development of the Geriatric Oral Health Assessment Index. J Dent Educ. 1990 Nov;54(11):680-7.
- Background: PubMed 8193981Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Background: PubMed 17244139Wong AH, Cheung CS, McGrath C. Developing a short form of Oral Health Impact Profile (OHIP) for dental aesthetics: OHIP-aesthetic. Community Dent Oral Epidemiol. 2007 Feb;35(1):64-72. doi: 10.1111/j.1600-0528.2007.00330.x.
- Background: PubMed 16139701McGrath C, Wong AH, Lo EC, Cheung CS. The sensitivity and responsiveness of an oral health related quality of life measure to tooth whitening. J Dent. 2005 Sep;33(8):697-702. doi: 10.1016/j.jdent.2005.01.012. Epub 2005 Mar 19.
- Background: PubMed 20860720Boiko OV, Baker SR, Gibson BJ, Locker D, Sufi F, Barlow AP, Robinson PG. Construction and validation of the quality of life measure for dentine hypersensitivity (DHEQ). J Clin Periodontol. 2010 Nov;37(11):973-80. doi: 10.1111/j.1600-051X.2010.01618.x. Epub 2010 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Domejean principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schiff Test, GOHAI questionnaire and OHIP questionnaire in people with Dentin Hypersensitivity and Quality of Life, run by University Hospital, Clermont-Ferrand at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the DHEQ-fr questionnaire (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466200, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.