Decontaminant Agent in the Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

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 Chronic
      Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the
      post-treatment clinical parameters and immunological and gingival microbial profiles in
      patients with CP, treated by either SRP in addition to desiccant or SRP alone.

      The null hypothesis to invalidate was that, after a one year follow-up, there were no
      variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between
      SRP + desiccant and SRP alone treatment.
    

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. 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.
    

Intervention name(s): Hybenx treatment (device); Scaling and Root Planing (SRP)
Intervention type(s): Procedure; Procedure
Intervention description(s): In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution.; The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
Intervention MeSH terms: Hybenx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Chronic Periodontitis; Hybenx; Desiccant agent; Healing; Microbiology; Periodontal Diseases; Periodontitis; Split-mouth clinical Study