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The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis

Primary Purpose

Labor Trial Refused

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Centella asiatica and bamboo salt
Centella asiatica
Sponsored by
LG Household & Health Care Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Trial Refused focused on measuring Centella asiatica, bamboo salt, dentifrice

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemical healthy individual
  • Normal alignment of teeth

Exclusion Criteria:

  • Recent antibiotic treatment
  • Existence of dental caries or periodontitis
  • Those needs emergency dental treatments
  • Natural teeth less than 20
  • Denture wearer
  • Oral appliance for orthodontic treatment
  • Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Centella asiatica and bamboo salt

    Centella asiatica

    Control dentifrice

    Arm Description

    Participants received a dentifrice which contains Centella asiatica, bamboo salt, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime). All participants used the assigned dentifrices for 4 days in each trial cycle.

    Participants received a dentifrice which contains Centella asiatica, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).

    Participants received a plain dentifrice which contains dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).

    Outcomes

    Primary Outcome Measures

    Gingivitis
    Gingival index is measured

    Secondary Outcome Measures

    Dental plaque
    Plaque index is measured

    Full Information

    First Posted
    November 24, 2015
    Last Updated
    November 26, 2015
    Sponsor
    LG Household & Health Care Ltd.
    Collaborators
    Seoul National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02616042
    Brief Title
    The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis
    Official Title
    The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Household & Health Care Ltd.
    Collaborators
    Seoul National University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to evaluate the effect of dentifrice formulations containing Centella asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which contains Centella asiatica and bamboo salt and the same participants will also use placebo for tooth brushing by cross-over design.
    Detailed Description
    With growing interest in plant-based products among researchers, many toothpastes with various herbal extracts have been introduced over the past few decades,Centella asiatica (CA), a small herb broadly cultivated in China, Southeast Asia, India and Oceanic countries, has long been used for therapeutic purposes since ancient times.CA has been reported to be useful in the treatment of skin diseases wound repair and healing of burn. In dentistry, few studies have explored the efficacy of CA. In one study, CA was demonstrated to be an effective supportive agent following periodontal treatment, resulting in reduced plaque and gingivitis. In spite of such wound healing properties of CA, its usage in dental field has been limited. Bamboo salt (BS) is a Korean folk remedy consisting of sea salt roasted in bamboo which has long been used for therapeutic purposes in Korea. Toothpastes containing BS has been sold in Korea for some decades. Some in vitro studies and animal studies using rats demonstrated anti-inflammatory effects of BS. Nevertheless, no human study has yet evaluated the effect of BS on periodontal health. Therefore, the new dentifrice containing CA and BS was developed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Trial Refused
    Keywords
    Centella asiatica, bamboo salt, dentifrice

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Centella asiatica and bamboo salt
    Arm Type
    Experimental
    Arm Description
    Participants received a dentifrice which contains Centella asiatica, bamboo salt, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime). All participants used the assigned dentifrices for 4 days in each trial cycle.
    Arm Title
    Centella asiatica
    Arm Type
    Experimental
    Arm Description
    Participants received a dentifrice which contains Centella asiatica, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).
    Arm Title
    Control dentifrice
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received a plain dentifrice which contains dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).
    Intervention Type
    Other
    Intervention Name(s)
    Centella asiatica and bamboo salt
    Intervention Description
    Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.
    Intervention Type
    Other
    Intervention Name(s)
    Centella asiatica
    Intervention Description
    Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.
    Primary Outcome Measure Information:
    Title
    Gingivitis
    Description
    Gingival index is measured
    Time Frame
    Four day
    Secondary Outcome Measure Information:
    Title
    Dental plaque
    Description
    Plaque index is measured
    Time Frame
    Four day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemical healthy individual Normal alignment of teeth Exclusion Criteria: Recent antibiotic treatment Existence of dental caries or periodontitis Those needs emergency dental treatments Natural teeth less than 20 Denture wearer Oral appliance for orthodontic treatment Pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyun-Duck Kim, DDS, PhD
    Organizational Affiliation
    Seoul National University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis

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