Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05061511 |
Other study ID # |
P-003 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2021 |
Est. completion date |
December 2023 |
Study information
Verified date |
May 2023 |
Source |
University of Parma |
Contact |
Elena Calciolari, DDS, MS, PhD |
Phone |
0521 033640 |
Email |
elena.calciolari[@]unipr.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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
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.