Expression of Inflammasomes in Peri-implantitis and Periodontitis

NCT05061511 | Completed

• 1 other identifier: P-003
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a laboratory-based study and it aims to evaluate the expression of inflammasomes in healthy gingiva and in the presence of peri-implantitis and periodontitis

Conditions

Periodontitis; Peri-Implantitis; Inflammation

Outcome Measures

Primary Outcomes (1)

• difference in expression of inflammasome-related transcripts ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20 between the 3 groups

  at the time of tissue collection (cross-sectional)

Secondary Outcomes (3)

• Qualitative histological description of gingival tissue in the 3 groups

  at the time of tissue collection (cross-sectional)

• Semi-quantitative assessment of inflammatory score within histology sections

  at the time of tissue collection (cross-sectional)

• Differences in the expression of inflammatory-immune related proteins, such as NLRP3, ASC-2, IL-1beta and IL-18 proteins, as assessed by immunodetection methods in the 3 groups

  at the time of tissue collection (cross-sectional)

Study Arms (3)

Healthy gingival tissue

healthy patients with absence of gingivitis (full-mouth bleeding score \<10%), no history of periodontal disease, having ≥20 teeth, and ≤1 tooth with interdental clinical attachment loss.

Other: Analysis of inflammasome expression; Other: Histological analysis

Periodontitis patients

patients with stage III or IV periodontitis, which means that these patients would have deep periodontal lesions that extend at least to the mid portion of the roots and whose management is complicated by the presence of intrabony defects, furcation involvement, history of periodontal tooth loss and localized ridge defects.

Other: Analysis of inflammasome expression; Other: Histological analysis

Peri-implantitis patients

patients affected by peri-implantitis, defined as radiographic evidence of bone loss ≥3 mm and probing pocket depth ≥6 mm around implants in conjunction with bleeding on probing; or defined as bleeding and/or suppuration on probing, increased probing pocket depth from a previous examination and loss of peri-implant bone.

Other: Analysis of inflammasome expression; Other: Histological analysis

Interventions

Analysis of inflammasome expression OTHER

RNA isolation, spectrophotometric quantification, reverse transcription to cDNA and relative quantification of gene expression using a quantitative reverse transcription polymerase chain reaction (qRT-PCR). Specific inflammasome-related transcripts will be investigated, including ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20. A qRT-PCR System (e.g. StepOne Plus, Applied Biosystems) will be used for the amplification and analysis of the PCR products. Expression data will be reported as the ratio between each investigated target gene and GAPDH (used as housekeeping endogenous control).

Healthy gingival tissue; Peri-implantitis patients; Periodontitis patients

Histological analysis OTHER

gingival tissue samples will be prepared for paraffin inclusion and different stains will be used to evaluate the histological features of the tissues, distribution of inflammatory cells and alignment of collagen fibers. Moreover, a trained examiner will assess semi-quantitatively the inflammatory infiltrate under light microscopy. The expression of inflammatory/immune-related proteins such as NLRP3, ASC-2, IL-1beta and IL-18 protein expressions will be compared among the three groups by immunodetection methods

Healthy gingival tissue; Peri-implantitis patients; Periodontitis patients

Eligibility Criteria

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

Study Population

The definition of the 3 groups will be based on the features described by the 2017 World Workshop on the classification of periodontal and peri-implant conditions (Berglundh et al., 2018, Papapanou et al., 2018).

You may qualify if:

• ≥18 years old

You may not qualify if:

• \<18 years old
• Medical history that includes uncontrolled diabetes or hepatic or renal failure, or other serious medical conditions or transmittable diseases e.g. serious cardiovascular disease or AIDS.
• History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Antibiotic, anti-inflammatory or anticoagulant therapy during the 2 weeks preceding the baseline exam.
• History of alcohol or drug abuse.
• In treatment with medications causing gingival overgrowth
• Smoking ≥10 cigarettes a day
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• University of Parma: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Centro Universitario di Odontoiatria

Parma, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival tissue will be collected in all 3 groups during surgical procedures such as periodontal surgeries, peri-implant surgeries, gingivectomies that the patients would undergo anyway, independently from taking part in the study.

MeSH Terms

Conditions

Periodontitis; Peri-Implantitis; Inflammation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ricercatore tipo B

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: September 29, 2021
• Study Start: May 1, 2021
• Primary Completion: December 14, 2023
• Study Completion: June 30, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)