Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466200
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-11
Brief Title:
Validation of a French Version of the DHEQ
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Validation of a French Version of the DHEQ - Oral Health-related Quality of Life and Dentin Hypersensitivity
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DHEQ-VALID
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 DHEQis developed and validated which is questionnaire assessing specifically the impact of DH on patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00861-66 | OTHER | None | None |