Clinical Trials Logo

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

NCT number NCT05061511
Study type Observational
Source University of Parma
Contact Elena Calciolari, DDS, MS, PhD
Phone 0521 033640
Email [email protected]
Status Recruiting
Start date May 1, 2021
Completion date September 2022

See also
  Status Clinical Trial Phase
Recruiting 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
Recruiting NCT05034159 - CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease 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
Recruiting NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Recruiting NCT03753204 - Salt-Sensitivity and Immunity Cell Activation Phase 1/Phase 2
Not yet recruiting NCT04857931 - Colchicine in HFpEF Phase 3
Not yet recruiting NCT04110925 - Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia N/A
Not yet recruiting NCT04041765 - IgM-Enriched Immunoglobulin for Neonatal Sepsis Phase 3
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Recruiting NCT02870764 - The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris Phase 4
Recruiting NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL Phase 2
Active, not recruiting NCT02856269 - Zinc Supplementation and Cardiovascular Risk in HIV N/A
Active, not recruiting NCT03502993 - Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)