Clinical trial NCT03047798: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Dental Plaque
Keywords: centella asiatica
bamboo salt
magnolia bark
gingivitis
dental plaque
mouthrinse
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: LG Household & Healthcare Ltd.
First posted: 2017-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gingivitis
timeFrame: two weeks
measure: Dental plaque
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: