Clinical Trials Directory

Trials / Completed

CompletedNCT04349878

Anaysis of Phytotherapy Agent Against Periodontitis

Effect of Phytotherapy Agens in Non Surgical Periodontitis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
University of Messina · Academic / Other
Sex
All
Age
32 Years – 70 Years
Healthy volunteers
Accepted

Summary

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Periodontitis (, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to phytotherapeutic drug or SRP alone.

Detailed description

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 34 patients, 18 men and 16 women, aged 27 to 65 (mean age 44.2) were assessed for eligibility . In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy. The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different non-contiguous interproximal sites using filter paper strips‡ as previously described. The levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent assay using an equation with software using a five polynomial parameter. Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, were treated as conventional Scaling and Root Planing (SRP) + phytotherapeutic drug (Neuridase), while the other group were treated as conventional SRP alone

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTgingival crevicular fluid evaluationanaysis of interleukins in gingival crevicular fluid

Timeline

Start date
2019-09-01
Primary completion
2020-03-01
Completion
2020-03-05
First posted
2020-04-16
Last updated
2020-04-20

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04349878. Inclusion in this directory is not an endorsement.