Evaluation of the role of saliva in the diagnosis of disease
| ISRCTN | ISRCTN16047134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16047134 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 208 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 08/10/2023
- Registration date
- 11/10/2023
- Last edited
- 11/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Saliva is a vital biological fluid that has all the advantages of being an excellent diagnostic tool. It is easy to collect and transport, requires a simple experience to take, safe and acceptable, and contains many vital elements that can be measured by various diagnostic techniques and similar to those used in blood tests. Many researchers have attempted to find salivary biomarkers for oral and systemic diseases using different protocols and techniques. This paper aims to study salivary biomarkers that related to oral diseases such as oral squamous cell carcinoma, lichen planus, recurrent oral stomatitis, and gastrointestinal diseases such as celiac disease.
The study aims to investigate the level of LDH in the blood and in saliva of patients with squamous cell oral cancer, and the level of Cortisol in the blood and in saliva of patients with lichen planus, and also the level of IgA in the blood and in saliva of patients with recurrent oral stomatitis and celiac disease.
Who can participate?
Adults aged 18 years or older with oral squamous cell carcinoma, lichen planus, recurrent oral stomatitis, celiac disease, and healthy controls.
What does the study involve?
Pariticipants provide a saliva sample and complete a questionnaire.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
February 2018 to January 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Aliaa Alshaar, aliaa.alshaar@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal investigator
Damascus University
Mazzeh Highway
Damascus
-
Syria
 ORCID ID |
0009-0003-8114-8399 |
|---|---|
| Phone | +963 958909620 |
| aliaa.alshaar@damascusuniversity.edu.sy |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational case-control study |
| Secondary study design | Case-control study |
| Scientific title | Evaluation of the role of saliva in the diagnosis of oral and systematic diseases (a case-control study) |
| Study acronym | ESRDOS |
| Study objectives | 1. The value of the salivary LDH changes in patients with oral spiny cell carcinoma, and the value of the LDH itself changes in the blood. 2. The value of the salivary cortisol changes in patients with lichen planus, and its value changes in the blood. 3. The value of salivary IgA changes in patients with recurrent oral thrush, and its value in the blood also changes. 4. The value of salivary IgA changes in patients with celiac disease, and its value changes in the blood. |
| Ethics approval(s) |
Approved 24/09/2018, The scientific research committee of the faculty of dentistry of Damascus University (Mazzeh highway, Damascus, -, Syria; +963 1133923192; info@damascusuniversity.edu.sy), ref: 208 |
| Health condition(s) or problem(s) studied | Evaluation of saliva role in diagnosis of oral cancer, lichen planus, aphthous stomatitis and celiac disease. |
| Intervention | Patients were included after performing an oral and histological examination to confirm the diagnosis of specific disease and obtaining a written consent from each patient. In addition, demographic details including age, gender, smoking habits and educational level were obtained. in lichen planus group participants answered the Beck Depression Rate Questionnaire (Beck). Subsequently, blood and saliva samples were collected from the individuals of both the study group and the control group between 8:00 am and 9:00 am to measure the morning cortisol level in lichen planus group and to measure LDH oral cancer group and to measure IgA in both of aphthous stomatitis and celiac disease groups. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured at a single time point: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 07/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | 1. Age is over 18 years old 2. Oral squamous cell carcinoma, lichen planus, recurrent oral stomatitis, celiac disease. |
| Key exclusion criteria | 1. Systemic diseases: such as diabetes, cardiovascular disease, renal disease, liver disorders and hypertension 2. On regular medications 3. Suffers from any mental disorder or any physical disability |
| Date of first enrolment | 10/10/2018 |
| Date of final enrolment | 25/09/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
11/10/2023: Trial's existence confirmed by Damascus University.
