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Decontaminant Agent in the Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hybenx treatment (device)
Scaling and Root Planing (SRP)
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Periodontitis focused on measuring Chronic Periodontitis, Hybenx, Desiccant agent, Healing, Microbiology, Periodontal Diseases, Periodontitis, Split-mouth clinical Study

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Hybenx treatment

    Scaling and Root Planing

    Arm Description

    Both quadrants included maxillary teeth 11-16 and 21-26. 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 SRP + desiccant (Hybenx). In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the marginal 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.

    Outcomes

    Primary Outcome Measures

    Probing depth (PD)
    Measured clinically in mm using a periodontal probe during periodontal chart

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 11, 2016
    Last Updated
    May 10, 2016
    Sponsor
    University of Messina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02657096
    Brief Title
    Decontaminant Agent in the Treatment of Chronic Periodontitis
    Official Title
    Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Messina

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Chronic Periodontitis, Hybenx, Desiccant agent, Healing, Microbiology, Periodontal Diseases, Periodontitis, Split-mouth clinical Study

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hybenx treatment
    Arm Type
    Experimental
    Arm Description
    Both quadrants included maxillary teeth 11-16 and 21-26. 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 SRP + desiccant (Hybenx). In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the marginal gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution.
    Arm Title
    Scaling and Root Planing
    Arm Type
    Sham Comparator
    Arm Description
    The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hybenx treatment (device)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and Root Planing (SRP)
    Intervention Description
    The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
    Primary Outcome Measure Information:
    Title
    Probing depth (PD)
    Description
    Measured clinically in mm using a periodontal probe during periodontal chart
    Time Frame
    At 365 days
    Secondary Outcome Measure Information:
    Title
    Plaque and Gingival Crevicular Fluid
    Description
    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.
    Time Frame
    At 365 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    61 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: good condition of general health, a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, no involvement of the furcation, a minimum of a six teeth per quadrant, respectively. Exclusion Criteria: periodontal therapy during the last 12 months, assumption of antibiotics during the last 6 months, pregnancy, any systemic condition which might affect the effects of the study treatment, previous or current radiation or immunosuppressive therapies, use of mouthwash containing antimicrobials during the previous 3 months, no use of hormonal contraceptives, medication by anti-inflammatory and immunosuppressive drugs, previous history of hard-drinking, smoking, class II and III tooth mobility.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giancarlo Cordasco, DDS
    Organizational Affiliation
    University of Messina
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26147153
    Citation
    Lombardo G, Signoretto C, Corrocher G, Pardo A, Pighi J, Rovera A, Caccuri 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 Microbiol. 2015 Jul;38(3):393-407. Epub 2015 Jul 6.
    Results Reference
    result

    Learn more about this trial

    Decontaminant Agent in the Treatment of Chronic Periodontitis

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