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Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

Primary Purpose

Gingivitis; Chronic, Smoking

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synbiotic Supplement
Placebo Oral Tablet
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis; Chronic focused on measuring gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy subjects
  • Clinical diagnosis of gingivitis

Exclusion Criteria:

  • Subjects who had used any systemic antibiotics in the previous 3 months,
  • Subjects who had used a product containing probiotics in the previous month
  • Systemic disease or condition that could interfere with the study results
  • Ongoing drug therapy that could affect the signs of gingivitis
  • Subjects who were received periodontal treatment in the last 6 months and
  • Allergic to milk and milk products

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Synbiotic supplements

    Placebo Oral Tablet

    Arm Description

    One synbiotic tablet, per day, during 30 days

    One placebo tablet , per day, during 30 days

    Outcomes

    Primary Outcome Measures

    Change from Baseline Interleukin (IL)-6 level of GCF at 2 months
    GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method
    Change from Baseline IL-8 level of GCF at 2 months
    GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method
    Change from Baseline IL-10 level of GCF at 2 months
    GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method

    Secondary Outcome Measures

    Change from Baseline GCF volume at 2 months
    Clinical parameter
    Change from Baseline Gingival Index at 2 months
    Clinical parameter
    Change from Baseline Plaque Index at 2 months
    Clinical parameter

    Full Information

    First Posted
    February 16, 2018
    Last Updated
    February 27, 2018
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03455192
    Brief Title
    Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
    Official Title
    The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 22, 2014 (Actual)
    Primary Completion Date
    June 29, 2015 (Actual)
    Study Completion Date
    June 29, 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets on the clinical parameters and the levels of selected inflammatory mediators in gingival crevicular fluid (GCF) in smokers and non-smokers with gingivitis. This study designed as a double-blind randomized placebo-controlled clinical trial.
    Detailed Description
    Some patients like smokers have ongoing host response even after bacterial plaque removal achieved. Therefore efforts to develop effective treatment approaches remain an important objective in the treatment of gingivitis to prevent periodontitis especially in patients at high risk for developing periodontitis as smokers. Smoking is a major risk factor for the incidence and the progression of periodontal diseases. The increased periodontal disease susceptibility in smokers is predominantly caused by changes in inflammatory and immune responses. Cigarette smoking also influences the amount and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their resident biofilm and display an ongoing host response even after biofilm removal. Different approaches were explored to reduce the negative effects of smoking on the outcomes of periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that beneficially affects the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract, by selectively stimulating the growth and/or by activating the metabolism of one or a limited number of health-promoting bacteria, and thus improving host welfare. Also in some cases, this may lead to a competitive advantage for the probiotics among with other bacteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis; Chronic, Smoking
    Keywords
    gingivitis, gingival crevicular fluid, probiotics, smoking, periodontal medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    double-blind randomized placebo-controlled clinical trial
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Synbiotic supplements
    Arm Type
    Experimental
    Arm Description
    One synbiotic tablet, per day, during 30 days
    Arm Title
    Placebo Oral Tablet
    Arm Type
    Placebo Comparator
    Arm Description
    One placebo tablet , per day, during 30 days
    Intervention Type
    Drug
    Intervention Name(s)
    Synbiotic Supplement
    Other Intervention Name(s)
    NOBEL (NBL) Probiotic Optima
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Tablet
    Primary Outcome Measure Information:
    Title
    Change from Baseline Interleukin (IL)-6 level of GCF at 2 months
    Description
    GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method
    Time Frame
    baseline, 1st and 2nd months
    Title
    Change from Baseline IL-8 level of GCF at 2 months
    Description
    GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method
    Time Frame
    baseline, 1st and 2nd months
    Title
    Change from Baseline IL-10 level of GCF at 2 months
    Description
    GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method
    Time Frame
    baseline, 1st and 2nd months
    Secondary Outcome Measure Information:
    Title
    Change from Baseline GCF volume at 2 months
    Description
    Clinical parameter
    Time Frame
    baseline, 1st and 2nd months
    Title
    Change from Baseline Gingival Index at 2 months
    Description
    Clinical parameter
    Time Frame
    baseline, 1st and 2nd months
    Title
    Change from Baseline Plaque Index at 2 months
    Description
    Clinical parameter
    Time Frame
    baseline, 1st and 2nd months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy subjects Clinical diagnosis of gingivitis Exclusion Criteria: Subjects who had used any systemic antibiotics in the previous 3 months, Subjects who had used a product containing probiotics in the previous month Systemic disease or condition that could interfere with the study results Ongoing drug therapy that could affect the signs of gingivitis Subjects who were received periodontal treatment in the last 6 months and Allergic to milk and milk products

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Randomization was performed by one researcher that had never any role in participant's treatment and clinical measurement processes (E.O.E). Patients' all measurements and treatments were made by a single researcher who doesn't know in which group participants were included (N.E.).
    IPD Sharing Time Frame
    study protocol : at the beginning of the study (july 2014) Clinical Study Report (CSR): july 2014, january 2015, july 2015, january 2016, april 2016
    IPD Sharing Access Criteria
    study protocol : with all researchers Clinical Study Report (CSR): Interviewed with all researchers by face to face

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    Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis

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