NCT04642716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 20, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

SalivaAmino acidsPeriodontitis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Amino acid Analysis

    2 years

Study Arms (1)

Salivary free amino acids profile observation

OTHER

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

Interventions

Also known as: Salivary free amino acids in patients with periodontitis
Salivary free amino acids profile observation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systemically healthy, clinical diagnosis of periodontitis, clinical diagnosis of periodontal health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 27587752BACKGROUND
  • 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.

    PMID: 17403271BACKGROUND
  • Cruzat VF, Krause M, Newsholme P. Amino acid supplementation and impact on immune function in the context of exercise. J Int Soc Sports Nutr. 2014 Dec 14;11(1):61. doi: 10.1186/s12970-014-0061-8. eCollection 2014.

    PMID: 25530736BACKGROUND
  • Song Zh, Tong G, Xiao K, Jiao le F, Ke Yl, Hu Ch. L-cysteine protects intestinal integrity, attenuates intestinal inflammation and oxidant stress, and modulates NF-kappaB and Nrf2 pathways in weaned piglets after LPS challenge. Innate Immun. 2016 Apr;22(3):152-61. doi: 10.1177/1753425916632303. Epub 2016 Feb 25.

    PMID: 26921254BACKGROUND
  • Sido B, Seel C, Hochlehnert A, Breitkreutz R, Droge W. Low intestinal glutamine level and low glutaminase activity in Crohn's disease: a rational for glutamine supplementation? Dig Dis Sci. 2006 Dec;51(12):2170-9. doi: 10.1007/s10620-006-9473-x. Epub 2006 Nov 1.

    PMID: 17078002BACKGROUND
  • Onder C, Kurgan S, Altingoz SM, Bagis N, Uyanik M, Serdar MA, Kantarci A, Gunhan M. Impact of non-surgical periodontal therapy on saliva and serum levels of markers of oxidative stress. Clin Oral Investig. 2017 Jul;21(6):1961-1969. doi: 10.1007/s00784-016-1984-z. Epub 2016 Nov 2.

    PMID: 27807715BACKGROUND
  • Dede FO, Ozden FO, Avci B. 8-hydroxy-deoxyguanosine levels in gingival crevicular fluid and saliva in patients with chronic periodontitis after initial periodontal treatment. J Periodontol. 2013 Jun;84(6):821-8. doi: 10.1902/jop.2012.120195. Epub 2012 Aug 16.

    PMID: 22897655BACKGROUND
  • Rajda C, Tajti J, Komoroczy R, Seres E, Klivenyi P, Vecsei L. Amino acids in the saliva of patients with migraine. Headache. 1999 Oct;39(9):644-9. doi: 10.1046/j.1526-4610.1999.3909644.x.

    PMID: 11279959BACKGROUND
  • Le A, Ng A, Kwan T, Cusmano-Ozog K, Cowan TM. A rapid, sensitive method for quantitative analysis of underivatized amino acids by liquid chromatography-tandem mass spectrometry (LC-MS/MS). J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Jan 1;944:166-74. doi: 10.1016/j.jchromb.2013.11.017. Epub 2013 Nov 18.

    PMID: 24316529BACKGROUND
  • Balci N, Kurgan S, Cekici A, Cakir T, Serdar MA. Free amino acid composition of saliva in patients with healthy periodontium and periodontitis. Clin Oral Investig. 2021 Jun;25(6):4175-4183. doi: 10.1007/s00784-021-03977-7. Epub 2021 May 11.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Saliva of periodontitis patients collected for analyzing free amino acids.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Nur Balci

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 24, 2020

Study Start

April 20, 2015

Primary Completion

April 15, 2017

Study Completion

August 3, 2017

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations