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

Primary Purpose

Periodontitis, Diagnoses Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Saliva collection of patients and salivary free amino acids analysis

About this trial

This is an interventional diagnostic trial for Periodontitis focused on measuring Saliva, Amino acids, Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Istanbul Medipol University, School of Dentistry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Salivary free amino acids profile observation

Arm Description

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) .

Outcomes

Primary Outcome Measures

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.

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)

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04642716

First Posted

November 20, 2020

Last Updated

November 20, 2020

Sponsor

Istanbul Medipol University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04642716

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 20, 2015 (Actual)

Primary Completion Date

April 15, 2017 (Actual)

Study Completion Date

August 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Diagnoses Disease

Keywords

Saliva, Amino acids, Periodontitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Saliva of periodontitis patients collected for analyzing free amino acids.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Salivary free amino acids profile observation

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Saliva collection of patients and salivary free amino acids analysis

Other Intervention Name(s)

Salivary free amino acids in patients with periodontitis

Primary Outcome Measure Information:

Title

Pocket probing depth

Description

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.

Time Frame

2 years

Title

Clinical attachment level

Description

Time Frame

2 years

Title

Bleeding on probing

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Amino acid Analysis

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Istanbul Medipol University, School of Dentistry

City

Istanbul

ZIP/Postal Code

34083

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27587752

Citation

Erratum for Wang et al. Glycine stimulates protein synthesis and inhibits oxidative stress in pig small intestinal epithelial cells. J Nutr 2014;144:1540-8. J Nutr. 2016 Sep;146(9):1813. doi: 10.3945/jn.116.236612. No abstract available.

Results Reference

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PubMed Identifier

17403271

Citation

Li P, Yin YL, Li D, Kim SW, Wu G. Amino acids and immune function. Br J Nutr. 2007 Aug;98(2):237-52. doi: 10.1017/S000711450769936X. Epub 2007 Apr 3.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Results Reference

derived

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

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