Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530940
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögrens Syndrome XERODIAG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögrens Syndrome XERODIAG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XERODIAG
Brief Summary:
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogrens syndrome Its diagnosis mainly relies on the measurement of salivary flow SF Performing this test is unpleasant for the patient lacks precision can be influenced by certain conditions and requires good patient cooperation Other alternatives such as the buccal Schirmer test can be used The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement This is a diagnostic study comparing a group of patients n90 with Sjogrens syndrome SS and normal SF 01 mlminute to a group of patients with SS and decreased SF 01 mlminute
Detailed Description:
Introduction
Xerostomia or dry mouth is a manifestation encountered in various physiological or pathological conditions One of its main causes is Sjogrens syndrome an autoimmune disease not specific to an organ characterized by lymphoplasmacytic infiltration of autoimmune origin affecting mainly the salivary and lacrimal glands
It is a debilitating condition leading to a significant impairment in quality of life primarily due to the dry mouth syndrome Apart from the risk of corneal perforation caused by xerophthalmia xerostomia is characterized by difficulty in chewing swallowing especially dry foods and speech It is also associated with a risk of caries dental decay and fungal infections Salivary flow measurement SF is the diagnostic method used to confirm xerostomia if it is less than 01 mlminute However it is a test that is poorly accepted by the patient lacks precision can be influenced by test conditions requires good patient cooperation and is unpleasant for the healthcare provider
The aim of our study is to demonstrate the non-inferiority of the buccal Schirmer test BST compared to SF measurement in patients with Sjogrens syndrome
1 Objectives
Primary objective Calculation of sensitivity Se specificity Sp negative predictive value NPV and positive predictive value PPV of the BST test compared to SF measurement
2 Clinical trial design
21 Study design
This is a diagnostic study comparing 2 groups
Group 1 consisting of 90 patients with SS and confirmed xerostomia by SF measurement 01 mlminute
Group 2 consisting of 90 patients with SS and normal SF 01 mlminute 22 Inclusion and exclusion criteria Inclusion criteria
Included patients meet the following criteria
age over 18 years
diagnosis of Sjogrens syndrome meeting the ACREULAR 2016 criteria Exclusion criteria
These include
Cognitive or dementia disorders
Pregnancy 23 Patient allocation
Patients meeting the inclusion criteria will be allocated to 2 groups based on SF
Group 1 patients with SF 01 mlminute
Group 2 patients with SF 01 mlminute 24 Interventions
For each group we will perform Figure 1
SF measurement This is the gold standard in diagnosing xerostomia This test involves instructing the patient to collect saliva in the morning without prior stimulation no smoking chewing gum or alcohol one hour before in a graduated tube for 15 minutes The patient should be comfortably seated with the head slightly tilted forward and mouth open to let the saliva flow A value less than 01 mlminute indicates xerostomia
Buccal Schirmer test BST It involves a strip of Whatman paper blotting paper placed in a polyethylene bag with the first 5 mm of the strip protruding from one end of the bag This end is then folded and placed under the patients tongue in contact with the floor of the mouth for 5 minutes The patient should be in a forward-leaning position hands on knees and eyes closed After five minutes the strip is removed and the soaked part is measured in centimeters A value 5 mm is considered pathological
Figure 1 Studys flow chart
3 Data collection methods
Epidemiological and clinical data will be collected through interviews and data extracted from medical records
Epidemiological data include age gender medical history such as diabetes chronic viral infection HCVHIV medications taken previous radiotherapy previous organ transplant smoking alcohol consumption
Clinical data include xerophthalmia parotid hypertrophy cutaneous xerosis vaginal dryness pulmonary involvement renal involvement central and peripheral neurological involvement
All these data will be entered using the SPSS software
4 Statistical analysis
It will be conducted using the SPSS software which will allow us to obtain the contingency table as shown in Table 1
Table 1 Contingency table SF
BST -
F1 F2
F3 F4
This table will be used to calculate
Sensitivity Se corresponds to the ratio F1F1F3
Specificity Sp corresponds to the ratio F4F4F2
Positive predictive value PPV corresponds to the ratio F1F1F2
Negative predictive value NPV corresponds to the ratio F4F4F3
Positive likelihood ratio PLR corresponds to the ratio Se1-Sp
Negative likelihood ratio NLR corresponds to the ratio 1-Se Sp
5 Ethics and informed consent
Informed consent will be obtained before inclusion in the study The patient must sign a consent form appendix 1 after being explained in a comprehensible and simple language about the trial appendix 2
This protocol will be submitted for approval to the ethics committee of the La Rabta University Hospital
Numbers will be assigned to patients according to their order of inclusion This number will be used for data entry to protect patient confidentiality
6 Funding and conflicts of interest
The buccal Schirmer tests and the necessary equipment for FS measurement will be funded by the investigator
All authors declare no conflicts of interest
Xerostomia or dry mouth is a manifestation encountered in various physiological or pathological conditions One of its main causes is Sjogrens syndrome an autoimmune disease not specific to an organ characterized by lymphoplasmacytic infiltration of autoimmune origin affecting mainly the salivary and lacrimal glands
It is a debilitating condition leading to a significant impairment in quality of life primarily due to the dry mouth syndrome Apart from the risk of corneal perforation caused by xerophthalmia xerostomia is characterized by difficulty in chewing swallowing especially dry foods and speech It is also associated with a risk of caries dental decay and fungal infections Salivary flow measurement SF is the diagnostic method used to confirm xerostomia if it is less than 01 mlminute However it is a test that is poorly accepted by the patient lacks precision can be influenced by test conditions requires good patient cooperation and is unpleasant for the healthcare provider
The aim of our study is to demonstrate the non-inferiority of the buccal Schirmer test BST compared to SF measurement in patients with Sjogrens syndrome
1 Objectives
Primary objective Calculation of sensitivity Se specificity Sp negative predictive value NPV and positive predictive value PPV of the BST test compared to SF measurement
2 Clinical trial design
21 Study design
This is a diagnostic study comparing 2 groups
Group 1 consisting of 90 patients with SS and confirmed xerostomia by SF measurement 01 mlminute
Group 2 consisting of 90 patients with SS and normal SF 01 mlminute 22 Inclusion and exclusion criteria Inclusion criteria
Included patients meet the following criteria
age over 18 years
diagnosis of Sjogrens syndrome meeting the ACREULAR 2016 criteria Exclusion criteria
These include
Cognitive or dementia disorders
Pregnancy 23 Patient allocation
Patients meeting the inclusion criteria will be allocated to 2 groups based on SF
Group 1 patients with SF 01 mlminute
Group 2 patients with SF 01 mlminute 24 Interventions
For each group we will perform Figure 1
SF measurement This is the gold standard in diagnosing xerostomia This test involves instructing the patient to collect saliva in the morning without prior stimulation no smoking chewing gum or alcohol one hour before in a graduated tube for 15 minutes The patient should be comfortably seated with the head slightly tilted forward and mouth open to let the saliva flow A value less than 01 mlminute indicates xerostomia
Buccal Schirmer test BST It involves a strip of Whatman paper blotting paper placed in a polyethylene bag with the first 5 mm of the strip protruding from one end of the bag This end is then folded and placed under the patients tongue in contact with the floor of the mouth for 5 minutes The patient should be in a forward-leaning position hands on knees and eyes closed After five minutes the strip is removed and the soaked part is measured in centimeters A value 5 mm is considered pathological
Figure 1 Studys flow chart
3 Data collection methods
Epidemiological and clinical data will be collected through interviews and data extracted from medical records
Epidemiological data include age gender medical history such as diabetes chronic viral infection HCVHIV medications taken previous radiotherapy previous organ transplant smoking alcohol consumption
Clinical data include xerophthalmia parotid hypertrophy cutaneous xerosis vaginal dryness pulmonary involvement renal involvement central and peripheral neurological involvement
All these data will be entered using the SPSS software
4 Statistical analysis
It will be conducted using the SPSS software which will allow us to obtain the contingency table as shown in Table 1
Table 1 Contingency table SF
BST -
F1 F2
F3 F4
This table will be used to calculate
Sensitivity Se corresponds to the ratio F1F1F3
Specificity Sp corresponds to the ratio F4F4F2
Positive predictive value PPV corresponds to the ratio F1F1F2
Negative predictive value NPV corresponds to the ratio F4F4F3
Positive likelihood ratio PLR corresponds to the ratio Se1-Sp
Negative likelihood ratio NLR corresponds to the ratio 1-Se Sp
5 Ethics and informed consent
Informed consent will be obtained before inclusion in the study The patient must sign a consent form appendix 1 after being explained in a comprehensible and simple language about the trial appendix 2
This protocol will be submitted for approval to the ethics committee of the La Rabta University Hospital
Numbers will be assigned to patients according to their order of inclusion This number will be used for data entry to protect patient confidentiality
6 Funding and conflicts of interest
The buccal Schirmer tests and the necessary equipment for FS measurement will be funded by the investigator
All authors declare no conflicts of interest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None