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

Phase 3

Completed

• Conditions: Gingivitis; Dental Plaque
• Interventions: Drug: Mouthrinse

• Registration Number: NCT03047798
• Lead Sponsor: Seoul National University

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2014-09-30
• Study Completion: 2014-10-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oil-water two-phase mouthrinse	Mouthrinse	This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in oil-water two-phase form.
Control	Mouthrinse	The control mouthrinse only contained sodium fluoride
aqueous single-phase mouthrinse	Mouthrinse	This contained sodium fluoride and the additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts in aqueous single-phase form.

Primary Outcome Measures

Name	Time	Method
Gingivitis	two weeks	Gingival index
Dental plaque	two weeks	Plaque index