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NCT Number: NCT05061511

Expression of Inflammasomes in Peri-implantitis and Periodontitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Universitario di Odontoiatria

Parma, Italy

About this study

This is a laboratory-based study involving 48 systemically healthy patients divided into: healthy (H) (n=16), periodontitis stage III-IV (n=16) (PE) and peri-implantitis (n=16) (PI).

Patients will be recruited at the Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma.

Only 1 study visit will be performed, which coincides with the day in which the patient will receive the dental/gingival surgery.

After signing an informed consent form, all participants will undergo a full-mouth periodontal and peri-implant examination, including plaque index (FMPS), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (FMBS) recorded by a calibrated examiner from six sites per tooth/implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual) excluding third molars and using a manual University of North Carolina (UNC-15) periodontal probe. This is a routine examination done as part of dental assessments that allows to place a diagnosis of health, periodontitis or peri-implantitis.

Gingival tissue samples will be collected during surgical procedures such as gingivectomy, crown lengthening and resective surgery. In order to minimise the influence of bacteria from dental plaque as a source of local inflammation and preferentially evaluate the influence of systemic inflammatory conditions on the periodontal tissues, and following the standard of practice in periodontal and peri-implant treatment, patients belonging to the PE and PI group would have received non-surgical therapy and practical and theoretical sessions on general oral hygiene within 3 months before collecting the biopsy (Sanz et al., 2020).

Samples of the H group will be obtained from sites with gingival index (GI) <1 (Loe, 1967), no clinical attachment loss and without bleeding on probing. For PE and PI groups, tissue samples will be selected from the areas involved in the surgical procedure presenting the greatest level of inflammation and with the deepest PPD.

Each patient will contribute to one gingival tissue sample only, which may include up to 3 neighboring teeth/implants.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old

Exclusion criteria

  • <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.

Treatment and study plan

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).

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

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

    Time frame: at the time of tissue collection (cross-sectional)

Secondary outcomes

  1. Qualitative histological description of gingival tissue in the 3 groups

    Time frame: at the time of tissue collection (cross-sectional)

  2. Semi-quantitative assessment of inflammatory score within histology sections

    Time frame: at the time of tissue collection (cross-sectional)

  3. 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

    Time frame: at the time of tissue collection (cross-sectional)

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • ITI International Team for Implantology, Switzerland

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 29, 2021
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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