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

November 20, 2020 updated by: Nur Balci, DDs, PhD, Istanbul Medipol University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Istanbul Medipol University, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Salivary free amino acids profile observation
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
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
Time Frame: 2 years
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
Time Frame: 2 years

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
Time Frame: 2 years
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
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2015

Primary Completion (ACTUAL)

April 15, 2017

Study Completion (ACTUAL)

August 3, 2017

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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