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

Sponsor

LG Household & Health Care Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02616042

Collaborator

Seoul National University (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Trial Refused	Other: Centella asiatica and bamboo salt Other: Centella asiatica	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis: a Randomized Clinical Trial

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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. 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.
Experimental: 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).	Other: 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. 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.
Placebo Comparator: 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).	Other: 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. 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

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.

Experimental: 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).

Other: 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.

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.

Placebo Comparator: 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).

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

Gingivitis [Four day]
Gingival index is measured

Secondary Outcome Measures

Dental plaque [Four day]
Plaque index is measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

LG Household & Health Care Ltd.
Seoul National University

Investigators

Principal Investigator: Hyun-Duck Kim, DDS, PhD, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LG Household & Health Care Ltd.

ClinicalTrials.gov Identifier:

NCT02616042

Other Study ID Numbers:

CRI09001

First Posted:

Nov 26, 2015

Last Update Posted:

Nov 30, 2015

Last Verified:

Nov 1, 2015

Keywords provided by LG Household & Health Care Ltd.

Centella asiatica

bamboo salt

dentifrice

Additional relevant MeSH terms:

Gingivitis

Study Results

No Results Posted as of Nov 30, 2015