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

NCT03047798 | Completed Phase 3

• 1 other identifier: S-D20140046
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis; Dental Plaque

Keywords

centella asiatica; bamboo salt; magnolia bark; gingivitis; dental plaque; mouthrinse

Outcome Measures

Primary Outcomes (2)

• Gingivitis

  Gingival index

  two weeks

• Dental plaque

  Plaque index

  two weeks

Study Arms (3)

aqueous single-phase mouthrinse

EXPERIMENTAL

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

Drug: Mouthrinse

oil-water two-phase mouthrinse

EXPERIMENTAL

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

Drug: Mouthrinse

Control

PLACEBO COMPARATOR

The control mouthrinse only contained sodium fluoride

Drug: Mouthrinse

Interventions

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.

Control; aqueous single-phase mouthrinse; oil-water two-phase mouthrinse

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults with at least 20 natural permanent teeth
• mild to moderate plaque (≥20% O'Leary index)
• mild gingivitis (20-30% BOP rate).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead
• LG Household & Healthcare Ltd.: collaborator

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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".
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Resident

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: June 1, 2014
• Primary Completion: September 30, 2014
• Study Completion: October 31, 2014
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share