Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease

Study Overview
=================
Brief Summary
-----------------
Amino acids (AAs) are organic molecules that are associated with inflammation and innate immunity diseases with critical roles in the cell repair and protection process. Our aim was to identify the free amino acids in saliva of a group of periodontitis patients and healthy individuals and additionally to assess their levels in different periodontal disease types and compare it to the healthy individuals.

Detailed Description
-----------------
The study consisted of three groups: healthy individuals (control(C); n=20), Stage III Grade B generalized periodontitis (GP-B; n=20), and Stage III Grade C generalized periodontitis (GP-C; n=20). Clinical periodontal parameters (plaque index (PI), gingival index (GI), probing depth (PPD), gingival recession (GR), clinical attachment level (CAL) and bleeding on probing (BOP)) were measured. The amino acid analysis in saliva was accomplished by liquid chromatography-mass spectrometry (LC MS/MS) as mean concentration.

Official Title
-----------------
Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease

Conditions
-----------------
Periodontitis, Diagnoses Disease

Intervention / Treatment
-----------------
* Other: Saliva collection of patients and salivary free amino acids analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemically healthy, clinical diagnosis of periodontitis, clinical diagnosis of periodontal health Exclusion Criteria: history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 3 months); nonsurgical periodontal treatment (previous 6 months); surgical periodontal treatment (previous 12 months); presence of <10 teeth; current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy); diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, smoking, or excessive alcohol consumption.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Saliva of periodontitis patients collected for analyzing free amino acids.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Salivary free amino acids profile observation<br>Saliva samples of periodontitis patients and healthy controls were collected. The AA analysis of the saliva was performed by LC-MS/MS by using the Thermo Scientific TSQ Quantum Access MAX (Thermo Scientific, Schaumburg, IL, USA) . | Other: Saliva collection of patients and salivary free amino acids analysis<br> <br> * Other names: Salivary free amino acids in patients with periodontitis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket probing depth | Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe. | 2 years | 
| Clinical attachment level | Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ. To calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth. In recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract) | 2 years | 
| Bleeding on probing | referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino acid Analysis | The AA analysis of the saliva was performed by LC-MS/MS by using the Thermo Scientific TSQ Quantum Access MAX (Thermo Scientific, Schaumburg, IL, USA) according to a modified version of Le et al.'s method. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saliva, Amino acids, Periodontitis