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. Subjects with a diagnosis of CP (Chronic Periodontitis) were enrolled in this clinical trial.
Study design Thirty-six patients, 19 men and 17 women, aged 27 to 65 (mean age 46.7) were assessed for eligibility at the Department of Biomedical, Odontostomatological Sciences and Morphological and Functional Images at the University of Messina, Messina, Italy. This trial was conducted in agreement with the CONSORT guidelines.
In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.
To permit the noninvasive specimen, all the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point present in the commercial kit† introduced into the base of the selected site for 30 s, a subgingival plaque sample was collected.
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, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP) + desiccant (Hybenx), while the contra-lateral quadrants were treated as conventional SRP alone.