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The Effect of Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica on Reducing Plaque and Gingivitis

Primary Purpose

Gingivitis, Dental Plaque

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mouthrinse
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring centella asiatica, bamboo salt, magnolia bark, gingivitis, dental plaque, mouthrinse

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults with at least 20 natural permanent teeth
  • mild to moderate plaque (≥20% O'Leary index)
  • mild gingivitis (20-30% BOP rate).

Exclusion Criteria:

  • individuals undergoing orthodontic treatment
  • individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth
  • diabetics
  • pregnant or lactating women
  • individuals taking antibiotics within the past one month
  • individuals who have used any mouthwashes for the past 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    aqueous single-phase mouthrinse

    oil-water two-phase mouthrinse

    Control

    Arm Description

    This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in aqueous single-phase form.

    This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in oil-water two-phase form.

    The control mouthrinse only contained sodium fluoride

    Outcomes

    Primary Outcome Measures

    Gingivitis
    Gingival index
    Dental plaque
    Plaque index

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    February 7, 2017
    Sponsor
    Seoul National University
    Collaborators
    LG Household & Healthcare Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03047798
    Brief Title
    The Effect of Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica on Reducing Plaque and Gingivitis
    Official Title
    Comparative Effects of Aqueous Single-phase and Oil-water Two-phase Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica Extracts on Reducing Gingivitis: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    September 30, 2014 (Actual)
    Study Completion Date
    October 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University
    Collaborators
    LG Household & Healthcare Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. Participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use placebo for tooth brushing by cross-over design.
    Detailed Description
    This is a randomized clinical intervention study with a cross-over design. The subjects are randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. The experimental mouthrinses all contain sodium fluoride and the ASM and OTM contain additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts. For the OTM, 50% essential oil is added to create an oil-water two-phase mouthrinse. Subjects are instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen is followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis, Dental Plaque
    Keywords
    centella asiatica, bamboo salt, magnolia bark, gingivitis, dental plaque, mouthrinse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Model Description
    Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The experiment was carried out in double-blind manner for the subjects and the examiner by providing the mouthrinses in opaque white bottles, labeled "A", "B" and "C".
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    aqueous single-phase mouthrinse
    Arm Type
    Experimental
    Arm Description
    This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in aqueous single-phase form.
    Arm Title
    oil-water two-phase mouthrinse
    Arm Type
    Experimental
    Arm Description
    This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in oil-water two-phase form.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    The control mouthrinse only contained sodium fluoride
    Intervention Type
    Drug
    Intervention Name(s)
    Mouthrinse
    Intervention Description
    A randomized clinical intervention study was planned with a cross-over design. The 34 subjects were randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse. Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.
    Primary Outcome Measure Information:
    Title
    Gingivitis
    Description
    Gingival index
    Time Frame
    two weeks
    Title
    Dental plaque
    Description
    Plaque index
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adults with at least 20 natural permanent teeth mild to moderate plaque (≥20% O'Leary index) mild gingivitis (20-30% BOP rate). Exclusion Criteria: individuals undergoing orthodontic treatment individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth diabetics pregnant or lactating women individuals taking antibiotics within the past one month individuals who have used any mouthwashes for the past 6 months.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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