Salivary Markers in Periodontal Disorders

NCT06576856 | Completed

• 1 other identifier: 20082
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The swelling of the gum, or periodontitis, is the leading cause for tooth loss, and currently affects up to 65 million adults only in the United States. One of the reasons for the widespread of periodontitis is because currently there are no definitive methods to detect the onset of gum disease. This lack of foresight impedes medical professionals to enact any preventive measures before the disease already manifests itself. We wish to expand our understanding towards the development of periodontitis by studying the expression and activity of salivary markers that have been associated with advanced stages of the disease, wherein the supporting tissues of tooth (periodontium) are already irreversibly destroyed. We hypothesize that a progressive shift in the expression of such salivary markers can indicate a change or evolution of periodontitis staging. In specific, we seek to establish a quantifiable relationship among levels of salivary proteases called MMPs, level of metal ions in different stages varying from health to periodontitis. The overall goal of this proposal is to enhance the predictability of periodontitis, as we are currently unable to diagnose the disease until the manifestation of its clinical signs and symptoms.

Conditions

Periodontal Disease, Staging, Salivary Markers, Diagnosis

Outcome Measures

Primary Outcomes (2)

• Matrix Metalloproteases (MMPs) Salivary Levels

  Levels of MMPs assessed by different immuno-assays.

  October 2024

• Levels of Metal Ions

  Levels of metal ions assessed by Inductively Coupled Plasma Dynamic Reaction Cell Mass Spectrometer

  October 2024

Secondary Outcomes (1)

• Potential Correlation of MMPs, Metal Ions and Peridontitis Staging

  October 2024

Study Arms (5)

Perio-Healthy

Individuals included in this cohort, other than meet the eligibility criteria, should present no clinical sign of periodontal disease. We anticipate to find from a very small number to none participants at this cohort. No intervention are anticipated.

Other: This is an observational study, no intervention is anticipated.

Periodontitis Stage I

Individuals included in this cohort, other than meet the eligibility criteria, should present clinical sign of periodontal defined as Stage I according to the American Academy of Periodontology. We anticipate low to moderate number of participants in this cohort. No interventions are anticipated.

Other: This is an observational study, no intervention is anticipated.

Periodontitis Stage II

Individuals included in this cohort, other than meet the eligibility criteria, should present clinical sign of periodontal defined as Stage II according to the American Academy of Periodontology. We anticipate a moderate number of participants in this cohort. No interventions are anticipated.

Other: This is an observational study, no intervention is anticipated.

Periodontitis Stage III

Individuals included in this cohort, other than meet the eligibility criteria, should present clinical sign of periodontal defined as Stage III according to the American Academy of Periodontology. We anticipate moderate to high number of participants in this cohort. No interventions are anticipated.

Other: This is an observational study, no intervention is anticipated.

Periodontitis Stage IV

Individuals included in this cohort, other than meet the eligibility criteria, should present clinical sign of periodontal defined as Stage IV according to the American Academy of Periodontology. We anticipate low to moderate number of participants in this cohort. No interventions are anticipated.

Other: This is an observational study, no intervention is anticipated.

Interventions

This is an observational study, no intervention is anticipated. OTHER

There is no intervention. This is an observational study.

Perio-Healthy; Periodontitis Stage I; Periodontitis Stage II; Periodontitis Stage III; Periodontitis Stage IV

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The literature does not display a consistent number of estimate participants for reliable assessment of salivary markers; with correlate studies reporting to have included from 100 to 1000 participants. We aim to invite up to 200 subjects to participate in this research. Subjects will be allocated into four categories following the four stages of periodontitis from AAP classification, plus a fifth category as periodontal health individuals for control group. The results of this cohort will be analyzed to detect an effect size of 0.5 at the 0.05 significance level.

You may not qualify if:

• (2) requiring definitive periodontal treatment/routine care; and
• (3) retaining a minimum of 20 teeth and without active carious lesions
• \) with systemic illness affecting their immune system (i.e. diabetes, rheumatoid arthritis, etc);
• (2) currently on chronic anti-inflammatory medications (i.e. steroids, TNFα-inhibitors, etc); and
• (3) previously underwent active periodontal therapy within the past 2 years;
• (4) who cannot read or speak English.

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Midwestern Univerity

Downers Grove, Illinois, 60515, United States

Location

Related Publications (13)

• Butler GS, Overall CM. Matrix metalloproteinase processing of signaling molecules to regulate inflammation. Periodontol 2000. 2013 Oct;63(1):123-48. doi: 10.1111/prd.12035.

  PMID: 23931058 BACKGROUND

• de Morais EF, Pinheiro JC, Leite RB, Santos PPA, Barboza CAG, Freitas RA. Matrix metalloproteinase-8 levels in periodontal disease patients: A systematic review. J Periodontal Res. 2018 Apr;53(2):156-163. doi: 10.1111/jre.12495. Epub 2017 Sep 12.

  PMID: 28898418 BACKGROUND

• Sorsa T, Gursoy UK, Nwhator S, Hernandez M, Tervahartiala T, Leppilahti J, Gursoy M, Kononen E, Emingil G, Pussinen PJ, Mantyla P. Analysis of matrix metalloproteinases, especially MMP-8, in gingival creviclular fluid, mouthrinse and saliva for monitoring periodontal diseases. Periodontol 2000. 2016 Feb;70(1):142-63. doi: 10.1111/prd.12101.

  PMID: 26662488 BACKGROUND

• Sorsa T, Tjaderhane L, Salo T. Matrix metalloproteinases (MMPs) in oral diseases. Oral Dis. 2004 Nov;10(6):311-8. doi: 10.1111/j.1601-0825.2004.01038.x.

  PMID: 15533204 BACKGROUND

• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.

  PMID: 29926957 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Giannobile WV, Beikler T, Kinney JS, Ramseier CA, Morelli T, Wong DT. Saliva as a diagnostic tool for periodontal disease: current state and future directions. Periodontol 2000. 2009;50:52-64. doi: 10.1111/j.1600-0757.2008.00288.x. No abstract available.

  PMID: 19388953 BACKGROUND

• Slots J. Periodontology: past, present, perspectives. Periodontol 2000. 2013 Jun;62(1):7-19. doi: 10.1111/prd.12011.

  PMID: 23574461 BACKGROUND

• Kwok V, Caton JG, Polson AM, Hunter PG. Application of evidence-based dentistry: from research to clinical periodontal practice. Periodontol 2000. 2012 Jun;59(1):61-74. doi: 10.1111/j.1600-0757.2011.00437.x.

  PMID: 22507060 BACKGROUND

• Lang NP, Tonetti MS. Periodontal diagnosis in treated periodontitis. Why, when and how to use clinical parameters. J Clin Periodontol. 1996 Mar;23(3 Pt 2):240-50. doi: 10.1111/j.1600-051x.1996.tb02083.x.

  PMID: 8707984 BACKGROUND

• Ji S, Choi Y. Point-of-care diagnosis of periodontitis using saliva: technically feasible but still a challenge. Front Cell Infect Microbiol. 2015 Sep 3;5:65. doi: 10.3389/fcimb.2015.00065. eCollection 2015.

  PMID: 26389079 BACKGROUND

• Listl S, Galloway J, Mossey PA, Marcenes W. Global Economic Impact of Dental Diseases. J Dent Res. 2015 Oct;94(10):1355-61. doi: 10.1177/0022034515602879. Epub 2015 Aug 28.

  PMID: 26318590 BACKGROUND

• Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.

  PMID: 25688694 BACKGROUND

Related Links

• . Many matrix metalloproteinase substrates modulate inflammation and hence, by processing these proteins, matrix metalloproteinases can orchestrate the inflammatory response.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary samples without DNA.

MeSH Terms

Conditions

Periodontal Diseases; Disease

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcela Rocha de Oliveira Carrilho, DDS, PhD

  Midwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: November 6, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2024
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)