NCT02657096

Decontaminant Agent in the Treatment of Chronic Periodontitis

Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: All
• Age: 18 Years – 61 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 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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Hybenx treatment (device)	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.
PROCEDURE	Scaling and Root Planing (SRP)	The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2016-01-15
• Last updated: 2016-05-11