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

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047798
• Other study ID #: S-D20140046
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2017
• Last updated: February 7, 2017
• Start date: June 1, 2014
• Est. completion date: October 31, 2014

Study information

• Verified date: February 2017
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 31, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

Drug:
• Mouthrinse
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University	LG Household & Healthcare Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingivitis	Gingival index	two weeks
Primary	Dental plaque	Plaque index	two weeks