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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03995979` - Inflammation and Protein Restriction	N/A
Completed	`NCT03255187` - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT03577223` - Egg Effects on the Immunomodulatory Properties of HDL	N/A
Completed	`NCT04383561` - Relationship Between LRG and Periodontal Disease	N/A
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed	`NCT06216015` - Exercise Training and Kidney Transplantation	N/A
Completed	`NCT04856748` - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed	`NCT05529693` - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population	N/A
Recruiting	`NCT05670301` - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases	N/A
Recruiting	`NCT05415397` - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs	Phase 3
Recruiting	`NCT04543877` - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study	Early Phase 1
Recruiting	`NCT05775731` - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed	`NCT03859934` - Metabolic Effects of Melatonin Treatment	Phase 1
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Completed	`NCT06065241` - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.	N/A
Completed	`NCT05864352` - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed	`NCT03318731` - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males	N/A
Not yet recruiting	`NCT06134076` - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota	N/A
Not yet recruiting	`NCT05910489` - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect

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