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Clinical study to determine the immunological characteristics of patients with peri-implantitis

Clinical Study of Immunological Characteristics in Patients with Peri-Implantitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010636
Enrollment
30
Registered
2025-06-13
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Inclusion criteria Adult patients aged 19 and older visiting the Periodontology Department of Yonsei University Dental Hospital In cases where there are teeth without periodontitis or gingivitis located in the opposite area that is symmetrical to the area where one or more implants are present.(Example: 26 for i16) (1) Normal group ? Individuals with at least one implant without inflammation ? Individuals without signs of inflammation in the periodontal tissues, including bleeding on probing ? Individuals without radiographic bone loss or clinical attachment loss (2) Peri-implantitis-Periodontitis group ? Individuals with implants where the periodontal pocket depth is measured at 6mm or more, showing bleeding on probing and radiographic bone loss of 3mm or more ? Individuals with a history of grade C, stage III/IV periodontitis I. Grade C: When one or more of the following criteria are met - Radiographic bone loss or clinical attachment loss: 2mm or more over 5 years - % bone loss/age: > 1.0 II. Stage III/IV: When one or more of the following criteria are met - Maximum interproximal attachment loss: = 5 mm - Radiographic bone loss: including the middle 1/3 and apical 1/3 - Tooth loss: present - Local complexity: probing depth = 6 mm - Horizontal bone loss + vertical bone loss = 3 mm - Class II or III furcation involvement - Moderate alveolar ridge defect (3) Peri-implantitis-Non-periodontitis group ? Individuals with implants where the periodontal pocket depth is measured at 6mm or more, showing bleeding on probing and radiographic bone loss of 3mm or more ? Individuals without a history of periodontitis in teeth other than the implant- No radiographic bone loss or clinical attachment loss observed- No signs of inflammation in the periodontal tissues, including bleeding on probing.

Exclusion criteria

Exclusion criteria: ? Currently smoking individuals ? Patients with uncontrolled systemic diseases ? Individuals with chronic lesions that have stabilized with reduced or absent inflammation ? Individuals with severe inflammation where dental treatment is impossible and tissue sampling is difficult. ? Those who have taken systemic antibiotics within the last 1 month ? In addition to the above, those who have any other clinical findings that, in the opinion of the principal investigator or staff, are medically inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Relative distribution of bacterial species in peri-implant tissues (gingival crevicular fluid, subgingival plaque, inflammatory connective tissue) based on 16S rRNA NGS analysis.;Inflammatory biomarker levels in peri-implant tissues (gingival crevicular fluid, subgingival plaque, inflammatory connective tissue) (ELISA analysis);Analysis of protein levels in the peri-implant surrounding tissues (gingival crevicular fluid);Transcriptome analysis of peri-implant tissues at the cellular level (single-cell RNA sequencing analysis)

Secondary

MeasureTime frame
Periodontal pocket depth;Bleeding on probe;Length of keratinized gingival;Plaque Index;Gingival Index;Mucosal Recession index;Vestibular depth;Marginal Bone Loss;delayed bleeding

Countries

Korea, Republic of

Contacts

Public ContactSeulbin Im

Yonsei University Health System, Dental Hospital

limsb@yuhs.ac+82-2-2228-2953

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026