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Completed

NCT Number: NCT03047798

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mouthrinse

Drug

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.

Primary outcomes

  1. Gingivitis

    Time frame: two weeks

    Gingival index

  2. Dental plaque

    Time frame: two weeks

    Plaque index

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Collaborators

  • LG Household & Healthcare Ltd.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2017
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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