Clinical trial NCT04642716: Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease
Official title: Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diagnoses Disease
Keywords: Saliva
Amino acids
Periodontitis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Saliva of periodontitis patients collected for analyzing free amino acids.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Pocket probing depth
timeFrame: 2 years
measure: Clinical attachment level
timeFrame: 2 years
measure: Bleeding on probing
timeFrame: 2 years
Secondary outcomes:
measure: Amino acid Analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
Study officials:
References:
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