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The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis

NCT ID: NCT02616042

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-12-31

Brief Summary

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This study aims to evaluate the effect of dentifrice formulations containing Centella asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which contains Centella asiatica and bamboo salt and the same participants will also use placebo for tooth brushing by cross-over design.

Detailed Description

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With growing interest in plant-based products among researchers, many toothpastes with various herbal extracts have been introduced over the past few decades,Centella asiatica (CA), a small herb broadly cultivated in China, Southeast Asia, India and Oceanic countries, has long been used for therapeutic purposes since ancient times.CA has been reported to be useful in the treatment of skin diseases wound repair and healing of burn. In dentistry, few studies have explored the efficacy of CA. In one study, CA was demonstrated to be an effective supportive agent following periodontal treatment, resulting in reduced plaque and gingivitis. In spite of such wound healing properties of CA, its usage in dental field has been limited.

Bamboo salt (BS) is a Korean folk remedy consisting of sea salt roasted in bamboo which has long been used for therapeutic purposes in Korea. Toothpastes containing BS has been sold in Korea for some decades. Some in vitro studies and animal studies using rats demonstrated anti-inflammatory effects of BS. Nevertheless, no human study has yet evaluated the effect of BS on periodontal health.

Therefore, the new dentifrice containing CA and BS was developed.

Conditions

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Labor Trial Refused

Keywords

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Centella asiatica bamboo salt dentifrice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Centella asiatica and bamboo salt

Participants received a dentifrice which contains Centella asiatica, bamboo salt, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime). All participants used the assigned dentifrices for 4 days in each trial cycle.

Group Type EXPERIMENTAL

Centella asiatica and bamboo salt

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.

Centella asiatica

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.

Centella asiatica

Participants received a dentifrice which contains Centella asiatica, dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).

Group Type EXPERIMENTAL

Centella asiatica and bamboo salt

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.

Centella asiatica

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.

Control dentifrice

Participants received a plain dentifrice which contains dental-type silica, sodium fluoride and aminocaproic acid. Each participant brushed their teeth using only the assigned dentifrices for 3 minutes twice a day (after breakfast and before bedtime).

Group Type PLACEBO_COMPARATOR

Centella asiatica and bamboo salt

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.

Centella asiatica

Intervention Type OTHER

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.

Interventions

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Centella asiatica and bamboo salt

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.

Intervention Type OTHER

Centella asiatica

Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Systemical healthy individual
* Normal alignment of teeth

Exclusion Criteria

* Recent antibiotic treatment
* Existence of dental caries or periodontitis
* Those needs emergency dental treatments
* Natural teeth less than 20
* Denture wearer
* Oral appliance for orthodontic treatment
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University

OTHER

Sponsor Role collaborator

LG Household & Health Care Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyun-Duck Kim, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Other Identifiers

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CRI09001

Identifier Type: -

Identifier Source: org_study_id