Decontaminant Agent in the Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657096
• Other study ID #: 918-10
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: May 10, 2016
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 61 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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,

6. use of mouthwash containing antimicrobials during the previous 3 months,

7. no use of hormonal contraceptives,

8. medication by anti-inflammatory and immunosuppressive drugs,

9. previous history of hard-drinking,

10. smoking,

11. class II and III tooth mobility.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.
• Scaling and Root Planing (SRP)
The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

References & Publications (1)

Lombardo G, Signoretto C, Corrocher G, Pardo A, Pighi J, Rovera A, Caccurri F, Nocini PF. A topical desiccant agent in association with ultrasonic debridement in the initial treatment of chronic periodontitis: a clinical and microbiological study. New Mic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth (PD)	Measured clinically in mm using a periodontal probe during periodontal chart	At 365 days	Yes
Secondary	Plaque and Gingival Crevicular Fluid	All the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point gently introduced into the base of the selected site for 30 s, a subgingival plaque and Gingival Crevicular Fluid sample was collected. Number of participants with treatment-related adverse events as assessed by enzyme-linked immunosorbent assay and the checkerboard DNA-DNA hybridization technique were used in order to check the secondary outcome.	At 365 days	Yes