Expression of Inflammasomes in Peri-implantitis & Periodontitis

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05061511
Study type	Observational
Source	University of Parma
Contact	Elena Calciolari, DDS, MS, PhD
Phone	0521 033640
Email	elena.calciolari@unipr.it
Status	Recruiting
Phase
Start date	May 1, 2021
Completion date	December 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Expression of Inflammasomes in Peri-implantitis and Periodontitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms