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Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasonic (Piezon Master 700) performed with Listerine
ultrasonic (Piezon Master 700) performed with CHX
ultrasonic (Piezon Master 700) performed with serum
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Halitosis focused on measuring Listerine, CHX

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution

Exclusion Criteria:

  • Individuals who presented any systemic disorders which cause halitosis (diabetes mellitus, nephropathy, liver disease, gastrointestinal diseases, respiratory problems), pregnancy or lactation, individuals who had taken antibiotics over the last 6 months or permanently used any drugs, individuals who had any form of periodontal treatment within 6 months prior to the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    test 1

    test 2

    control

    Arm Description

    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with CHX (Drogsan, Istanbul, Turkey, 0.2%) was performed at one session for once.

    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with Listerine (Johnson & Johnson, Istanbul, Turkey, containing, 21.6% ethanol, 0.092% eucalyptol, 0.064% thymol, 0.042% menthol and 0.06% methyl salicylate) was performed at one session for once.

    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with distilled water was performed at one session for once.

    Outcomes

    Primary Outcome Measures

    Periodontal Pocket Depth (PPD)
    PD were evaluated: at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.

    Secondary Outcome Measures

    halimeter values
    The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.

    Full Information

    First Posted
    March 9, 2018
    Last Updated
    March 15, 2018
    Sponsor
    Near East University, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03468595
    Brief Title
    Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis
    Official Title
    Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis With Subgingival Ultrasonic Instrumentation in Periodontitis Patients: A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Near East University, Turkey

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters and halitosis. Ninety patients with periodontal disease participated for the study. Individuals were randomly selected to a control and test groups. At baseline, all subjects completed a questionnaire and carried out an examination. Standard periodontal outcome variables were assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Halitosis
    Keywords
    Listerine, CHX

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    test 1
    Arm Type
    Experimental
    Arm Description
    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with CHX (Drogsan, Istanbul, Turkey, 0.2%) was performed at one session for once.
    Arm Title
    test 2
    Arm Type
    Experimental
    Arm Description
    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with Listerine (Johnson & Johnson, Istanbul, Turkey, containing, 21.6% ethanol, 0.092% eucalyptol, 0.064% thymol, 0.042% menthol and 0.06% methyl salicylate) was performed at one session for once.
    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with distilled water was performed at one session for once.
    Intervention Type
    Device
    Intervention Name(s)
    ultrasonic (Piezon Master 700) performed with Listerine
    Other Intervention Name(s)
    EMS, Nyon
    Intervention Type
    Device
    Intervention Name(s)
    ultrasonic (Piezon Master 700) performed with CHX
    Other Intervention Name(s)
    EMS, Nyon
    Intervention Type
    Device
    Intervention Name(s)
    ultrasonic (Piezon Master 700) performed with serum
    Other Intervention Name(s)
    EMS, Nyon
    Primary Outcome Measure Information:
    Title
    Periodontal Pocket Depth (PPD)
    Description
    PD were evaluated: at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.
    Time Frame
    30 day
    Secondary Outcome Measure Information:
    Title
    halimeter values
    Description
    The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.
    Time Frame
    30 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution Exclusion Criteria: Individuals who presented any systemic disorders which cause halitosis (diabetes mellitus, nephropathy, liver disease, gastrointestinal diseases, respiratory problems), pregnancy or lactation, individuals who had taken antibiotics over the last 6 months or permanently used any drugs, individuals who had any form of periodontal treatment within 6 months prior to the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hasan Guney YILMAZ, DDS, PhD
    Organizational Affiliation
    Near East University, Faculty of Dentistry
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis

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