Signal-Transducing Adaptor Proteins in Periodontal Disease

NCT07751393 | Completed

• 1 other identifier: IU-2024-3795
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at certain proteins in the gums, saliva, and gum fluid of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied called STAP-1, STAP-2, STAT3, STAT5A, NLRP3, and CASP3, are known to be involved in inflammation and cell health in other diseases, but their role in gum disease is not well understood. Seventy-five healthy adults will be grouped by their gum health status. Samples of saliva and gum fluid will be collected and tested, and gum tissue samples will be collected from a subset of participants during routine dental treatment. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease. The results are expected to show whether these proteins are found at different levels in people with periodontitis compared to those with healthy gums, suggesting they may play a role in how gum disease develops and progresses. This information may help researchers better understand the biological processes behind periodontal disease and could eventually contribute to new ways of detecting or treating it.

Conditions

Periodontitis; Gingivitis

Keywords

periodontitis; gingivitis; STAP family; inflammation; GCF

Outcome Measures

Primary Outcomes (1)

• GCF, saliva and Gingival levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3

  Gene expression (RT-PCR, relative fold change via 2\^-ΔΔCT method)levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 were measured in gingiva of participants. Protein levels of STAP-1, STAP-2, STAT3, STAT5A, NLRP3 and CASP3 in GCF and saliva were measured by ELISA in study participants.

  From may to December 2024

Study Arms (3)

periodontally healthy

periodontally healthy participants

gingivitis

patients with gingivitis

periodontitis

patients with periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 60 years attending the periodontology clinic were enrolled and classified into three groups based on clinical periodontal parameters according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III). Exclusion criteria included any systemic disease, regular medication use, smoking, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 75 participants (25 per group; 38 male, 37 female) were included.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Kubra Aral , Phd Ext. 422 341 01 06 kubra.aral@inonu.edu.tr

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (4)

• Aral K, Aral CA, Kapila Y. The role of caspase-8, caspase-9, and apoptosis inducing factor in periodontal disease. J Periodontol. 2019 Mar;90(3):288-294. doi: 10.1002/JPER.17-0716. Epub 2018 Oct 26.

  PMID: 30311940 BACKGROUND

• Aral K, Milward MR, Kapila Y, Berdeli A, Cooper PR. Inflammasomes and their regulation in periodontal disease: A review. J Periodontal Res. 2020 Aug;55(4):473-487. doi: 10.1111/jre.12733. Epub 2020 Jan 20.

  PMID: 31960443 BACKGROUND

• Luo L, Wang F, Xu X, Ma M, Kuang G, Zhang Y, Wang D, Li W, Zhang N, Zhao K. STAT3 promotes NLRP3 inflammasome activation by mediating NLRP3 mitochondrial translocation. Exp Mol Med. 2024 Sep;56(9):1980-1990. doi: 10.1038/s12276-024-01298-9. Epub 2024 Sep 2.

  PMID: 39218978 BACKGROUND

• Kashiwakura JI, Oritani K, Matsuda T. The Functional Properties and Physiological Roles of Signal-Transducing Adaptor Protein-2 in the Pathogenesis of Inflammatory and Immune Disorders. Biomedicines. 2022 Nov 30;10(12):3079. doi: 10.3390/biomedicines10123079.

  PMID: 36551835 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual gingival crevicular fluid (GCF) samples will be retained as backup specimens in case repeat ELISA analysis is required due to technical issues (e.g., assay failure, insufficient sample volume, or inconclusive results). Retained samples will not be used for DNA extraction and will be stored at -80°C.

MeSH Terms

Conditions

Periodontitis; Gingivitis; Inflammation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 24 months following article publication
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by the corresponding author, for the purpose of achieving the aims outlined in the approved proposal.

Locations

TU (1)