Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03009786 |
| Other study ID # |
PO16109* |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2017 |
| Est. completion date |
February 20, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main objective of this study is to achieve cross-cultural and psychometric validation of
the Xerostomia Inventory initially developed in English language into French Language. This
will be achieved in two stages: First, cross-cultural validation, and a second, psychometric
validation The cross-cultural validation will be performed according to the methodology of
the Institute for Work and Health, according to the recommended six phases. In a second step,
the psychometric validation will be done using longitudinal study. Indeed, an observational,
longitudinal, and prospective study will be set up. Analysis of the results will help define
the feasibility and acceptability of the tool, its validity (content validity, perceived
validity, construct validity, concurrent validity, and discriminant validity), its
reliability (internal consistency and reproducibility over time). Longitudinal follow-up of
patients is expected to also assess the predictive validity and responsiveness.
Description:
Medical context:
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.
