Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05174494 |
Other study ID # |
121/20/PO |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2, 2020 |
Est. completion date |
November 30, 2022 |
Study information
Verified date |
January 2023 |
Source |
University of Catania |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In light of the controversy that are already approved but that however still exists regarding
the efficacy and influence the management of Periodontitis, the aim of this study was to
evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in
patients with periodontitis, treated by either Intensive scaling and root planing (SRP)
treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.
The null hypothesis to invalidate was that there were no variations, in relation to clinical
and serum CRP and NT-proBNP.
Description:
This trial was conducted in accordance with the World Medical Association's Declaration of
Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study
protocol and each patient was carefully informed about the possible inherent risks of the
study and provided their informed written consent.
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The
inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for
each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the
furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria
were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during
the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of
the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use
of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal
contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous
history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly
undergo to full mouth SRP (test group) or oral hygiene treatment (control group)