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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Mouthrinse

Study type: Interventional

Funder types: Other

Identifiers

NCT03047798

S-D20140046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 3 patient groups, including a placebo group

aqueous single-phase mouthrinse

Experimental group

Description:

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

Treatment:

Drug: Mouthrinse

oil-water two-phase mouthrinse

Experimental group

Description:

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

Treatment:

Drug: Mouthrinse

Control

Placebo Comparator group

Description:

The control mouthrinse only contained sodium fluoride

Treatment:

Drug: Mouthrinse