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
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
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
NCT ID
NCT03047798
First Posted
February 7, 2017
Last Updated
February 7, 2017
Sponsor
Seoul National University
Collaborators
LG Household & Healthcare Ltd.
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
The Effect of Mouthrinses Containing Bamboo Salt, Magnolia Bark and Centella Asiatica on Reducing Plaque and Gingivitis
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