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PeriodontitisNCT04642716

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

A study testing Saliva collection of patients and salivary free amino acids analysis in people with Periodontitis and Diagnoses Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis, Diagnoses Disease
What is being tested?
Saliva collection of patients and salivary free amino acids analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2015to 3 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Medipol University, School of Dentistry

    Istanbul, 34083

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Saliva collection of patients and salivary free amino acids analysis
Keywords
Saliva, Amino acids, Periodontitis
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saliva collection of patients and salivary free amino acids analysisOther

    Also called Salivary free amino acids in patients with periodontitis

Study groups in NCT04642716
Study groupRoleWhat they receive
Salivary free amino acids profile observationOtherSaliva 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) .
Receives: Other: Saliva collection of patients and salivary free amino acids analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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)

    Measured: 2 years

  3. 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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start20 Apr 2015
  3. Primary completion15 Apr 2017
  4. Study completion3 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Saliva of periodontitis patients collected for analyzing free amino acids.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642716
Sponsor's protocol ID
10840098-327
Status last verified
Nov 2020
First submitted
20 Nov 2020
Last updated
24 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27587752

  • 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.

    PubMed 17403271

  • 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.

    PubMed 25530736

  • 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.

    PubMed 26921254

  • 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.

    PubMed 17078002

  • 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.

    PubMed 27807715

  • 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.

    PubMed 22897655

  • 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.

    PubMed 11279959

  • 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.

    PubMed 24316529

  • 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.

    PubMed 33977387

Questions about this trial

What is this clinical trial studying?

A study testing Saliva collection of patients and salivary free amino acids analysis in people with Periodontitis and Diagnoses Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pocket probing depth (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642716, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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