Validation of the French Version of the Xerostomia Inventory (XIvf)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03009786|
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment|
|Xerostomia||Other: Measurement of salivary flow|
There is an intra-individual and inter-individual variability in the production of saliva. Various factors influence the production of saliva. Saliva flow tends to decrease with age, sleep, emotional state, and to increase after eating, and during pregnancy. Some drugs increase the salivary flow, others decrease it. Tobacco and alcohol tend to impair the quality of the saliva. Furthermore, 43% of 40-64 years and 61% over 65 take at least one antisialic medication. Lack of saliva can cause problems chewing, swallowing, speaking, and tasting perceptions. There is an increase in the number of oropharyngeal candidiasis that affects feeding behaviors and would be responsible for malnutrition in the elderly, and an increase in the number of caries for subjects still toothed. For edentulous or partially dentate subjects, salivary film plays two roles: the first is to allow adhesion of complete or almost complete dentures; the following is to protect the oral mucosa. In subjects suffering from mouth dryness the denture becomes difficult. In addition, saliva is essential for the first phase of digestion, for the creation of a correct bolus. There are several methods to measure the salivary flow. The most common include:
- The measurement of salivary flow at rest, the subject leaves the saliva in his mouth then allowed to flow slowly and spit into a funnel connected to a graduated tube for either 6 or 12 minutes. This test can be performed either at rest or stimulated using a paraffin cube or citric acid. These tests are long and therefore not suitable for the elderly.
- The salivary flow measurements using a compress weight of about 0.95 g is weighed and then placed under the tongue of the subject for 5 minutes. Once the elapsed time, the pad is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes. This test can be done like the previous one at rest or after stimulation.
Secretion at rest varies authors 0,05mℓ / min 0,4mℓ / min. The mouth dryness is defined by a total salivary flow rate below 0.1 unstimulated +/- 0,1mℓ / min ≤ 0.16 mℓ / min. The salivary potential of hydrogen (pH) varies between 6.5 and 8.5. Decreased salivary flow will cause a decrease in pH and promote the degradation of the oral health status.
Tool: The Xerostomia Inventory is a scale of measurement of xerostomia with eleven items used in daily practice or research, which results in a sum score giving a score representing the severity of the drought oral perceived by the subject. This tool was developed in 1999 and covers both experimental and behavioral aspects of xerostomia, and showed acceptable psychometric characteristics. Today, this tool is available in English, Spanish and Portuguese languages With this study a tool to measure xerostomia will be available in French; it may be used in clinical studies and in the daily practice of the dentist and or speech therapists to obtain a subjective measure of dry mouth, particularly in the elderly who are the most vulnerable subjects consequences of xerostomia. Currently there is no way to measure xerostomia, it is difficult to assess the processes associated with the patient and case treatment administered it is impossible to say whether it is effective or not.
The aim of this study is to achieve cross-cultural and psychometric validation version of the Xerostomia Inventory into French Language.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||November 5, 2022|
|Estimated Study Completion Date :||November 2023|
|Elderly institutionalized subjects or outpatients||
Other: Measurement of salivary flow
A compress of about 0.95 g which is weighed and then placed under the tongue of the subject for 5 minutes. Once the time has elapsed, the compress is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes
- The psychometric properties of the Xerostomia Inventory measured by questionnaire [ Time Frame: month 6 ]The Xerostomia Inventory to be validated is an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia; higher scores represent more severe symptoms. Respondents are asked to choose one of five responses: Never: 1 point; Hardly ever: 2 points; Occasionally: 3 points; Fairly often: 4 points; Very often: 5 points; to the following statements referring to the previous 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009786
|Contact: Pierrard Loïc||326787878 ext firstname.lastname@example.org|
|France, Reims, France, 51092|
|Contact: Damien JOLLY 326788472 ext 33 email@example.com|