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

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

Sponsors

Lead Sponsor: Seoul National University

Collaborator: LG Household & Healthcare Ltd.

Source 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.

Overall Status Completed
Start Date June 1, 2014
Completion Date October 31, 2014
Primary Completion Date September 30, 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Gingivitis two weeks
Dental plaque two weeks
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mouthrinse

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.

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.

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University

Investigator Full Name: Seungjae Choi

Investigator Title: Dr. Resident

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: aqueous single-phase mouthrinse

Type: Experimental

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

Label: oil-water two-phase mouthrinse

Type: Experimental

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

Label: Control

Type: Placebo Comparator

Description: The control mouthrinse only contained sodium fluoride

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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".

Source: ClinicalTrials.gov