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

Labor Trial Refused Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616042
• Other study ID #: CRI09001
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2015
• Last updated: November 26, 2015
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2015
• Source: LG Household & Health Care Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingivitis
• Labor Trial Refused

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LG Household & Health Care Ltd.	Seoul National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingivitis	Gingival index is measured	Four day	No
Secondary	Dental plaque	Plaque index is measured	Four day	No