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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04642716
Other study ID # 10840098-327
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2015
Est. completion date August 3, 2017

Study information

Verified date November 2020
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 3, 2017
Est. primary completion date April 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Saliva collection of patients and salivary free amino acids analysis


Locations

Country Name City State
Turkey Istanbul Medipol University, School of Dentistry Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View Citation

Dede FÖ, 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. — View 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. — View Citation

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. — View 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. Epub 2007 Apr 3. Review. — View Citation

Önder C, Kurgan S, Altingöz SM, Bagis N, Uyanik M, Serdar MA, Kantarci A, Günhan 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. — View Citation

Rajda C, Tajti J, Komoróczy R, Seres E, Klivényi P, Vécsei L. Amino acids in the saliva of patients with migraine. Headache. 1999 Oct;39(9):644-9. — View Citation

Sido B, Seel C, Hochlehnert A, Breitkreutz R, Dröge 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. Epub 2006 Nov 1. — View Citation

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-?B 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
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