NCT05061511

Expression of Inflammasomes in Peri-implantitis and Periodontitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Detailed description

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.

Conditions

• Periodontitis
• Peri-Implantitis
• Inflammation

Interventions

Type	Name	Description
OTHER	Analysis of inflammasome expression	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).
OTHER	Histological analysis	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

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-14
• Completion: 2024-06-30
• First posted: 2021-09-29
• Last updated: 2025-04-22

Locations

1 site across 1 country: Italy