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

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

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.

Study Overview

• Status: Completed
• Conditions: Labor Trial Refused
• Intervention / Treatment: Other: Centella asiatica and bamboo salt; Other: Centella asiatica

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingivitis	Gingival index is measured	Four day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental plaque	Plaque index is measured	Four day

Collaborators and Investigators

• Sponsor: LG Household & Health Care Ltd.
• Collaborators: Seoul National University
• Investigators: Principal Investigator: Hyun-Duck Kim, DDS, PhD, Seoul National University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 26, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Centella asiatica; dentifrice; bamboo salt
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: CRI09001