Objective measurement of xerostomia (OMX)
- Conditions
- Dry mouthXerostomiasD014987
- Registration Number
- JPRN-jRCTs032210632
- Lead Sponsor
- Kazuhiro Ikeura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Well-controlled blood disease and collagen disease.
No acute oral manifestations of dental caries, periodontal disease, or oral mucositis.
These are the main selection criteria, and the details of the target population are shown below.
Patients with xerostomia
(1) Patients with chronic graft-versus-host disease and Sjogren's syndrome who have subjective symptoms of xerostomia and whose salivary secretion during stimulation is less than 10 ml/10 min in the gum test and less than 2 g/2 min in the Saxon test. No history of treatment with salivary stimulants, artificial saliva or oral moisturizers for xerostomia.
(2) Males and females between the ages of 20 and 90 years old at the time of consent, who, after receiving sufficient explanations about participation in this study, and with sufficient understanding by the subject himself/herself, can give written consent of his/her own free will.
(3) Those who have given their consent to the examination at a regular dental or oral surgery clinic.
(4) Patients who are able to attend regular outpatient clinics for examination and treatment.
(5) Patients with no abnormalities in opening and closing movements, swallowing, or respiratory function
(6) Patients must be able to hold their breath for 5 seconds.
Basis for setting
For (1), patients who have been diagnosed with a target disease will be selected.
For (1), to select patients who have been diagnosed with the target disease, and for (2) to (6), from an ethical perspective.
Rationale for setting
1) Patients who do not have chronic graft-versus-host disease or Sjogren's syndrome, do not have subjective symptoms of xerostomia, and whose salivary secretion during stimulation is 10 ml/10 min or more in the gum test and 2 g/2 min or more in the Saxon test. No history of treatment with salivary stimulants, artificial saliva or oral moisturizers for xerostomia.
2) Males and females between the ages of 20 and 90 years old at the time of consent, who, after receiving sufficient explanations about participation in this study, and with sufficient understanding by the subject himself/herself, can give written consent of his/her own free will.
3) Those who have given their consent to the examination at a regular dental or oral surgery clinic.
4) Those who are able to attend regular outpatient clinics for examination and treatment.
5) Patients with no abnormalities in opening and closing movements, swallowing, or respiratory function.
6) Patients must be able to hold their breath for 5 seconds.
Basis for setting
(1) For (1), to select healthy persons.
For (2) to (6), the selection was made from an ethical perspective.
Poorly controlled blood diseases and collagen diseases.
Patients with acute symptoms of oral caries, periodontal disease, or oral mucositis.
These are the main exclusion criteria, and the details of the target population are shown below.
Patients with xerostomia
(1) Patients with chronic graft-versus-host disease and Sjogren's syndrome who have no subjective symptoms of xerostomia and whose salivary secretion during stimulation is 10 ml/10 minutes or more in the gum test and 2 g/2 minutes or more in the Saxon test. No history of treatment with salivary stimulants, artificial saliva or oral moisturizers for xerostomia. A history of treatment with salivary stimulants, artificial saliva or oral moisturizers for xerostomia.
(2) Males and females between the ages of 20 and 90 years old at the time of consent, who have received sufficient explanation for participation in this study, and whose written consent of their own free will cannot be obtained after they have fully understood it.
(3) Patients who are unable to give consent for examinations at regular dental and oral surgery clinics.
(4) Patients who are unable to attend regular outpatient clinics for examination and treatment
(5) Patients with abnormalities in opening and closing movements, swallowing, or respiratory function
(6) Patients who are unable to hold their breath for 5 seconds
Basis for setting
For (1), patients with xerostomia who do not meet the eligibility criteria will be excluded.
For (1), to exclude patients with xerostomia who do not meet the eligibility criteria.
For (2) to (6), from an ethical perspective.
Healthy subjects
1) Patients who do not have chronic graft-versus-host disease or Sjogren's syndrome, have subjective symptoms of xerostomia, and whose salivary secretion during stimulation is less than 10 ml/10 min in the gum test and less than 2 g/2 min in the Saxon test. A history of treatment with salivary stimulants, artificial saliva or oral moisturizers for xerostomia.
(2) Males and females between the ages of 20 and 90 years old at the time of consent, who have received sufficient explanation for participation in this study, and whose written consent of their own free will cannot be obtained after they have fully understood it.
(3) Patients who are unable to give consent for examinations at regular dental and oral surgery clinics.
(4) Patients who are unable to attend regular outpatient clinics for examination and treatment
(5) Patients with abnormalities in opening and closing movements, swallowing, or respiratory function
(6) Patients who are unable to hold their breath for 5 seconds
Basis for setting
For (1), to exclude healthy subjects who do not meet the eligibility criteria.
(1) is to exclude healthy subjects who do not meet the eligibility criteria.
(2) to (6) were set from an ethical perspective.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method