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Trial record 33 of 36 for:    AMINOCAPROIC ACID

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

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ClinicalTrials.gov Identifier: NCT02616042
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : November 30, 2015
Sponsor:
Collaborator:
Seoul National University
Information provided by (Responsible Party):
LG Household & Health Care Ltd.

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.


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Study Type : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

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.




Primary Outcome Measures :
  1. Gingivitis [ Time Frame: Four day ]
    Gingival index is measured


Secondary Outcome Measures :
  1. Dental plaque [ Time Frame: Four day ]
    Plaque index is measured



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616042


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

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Responsible Party: LG Household & Health Care Ltd.
ClinicalTrials.gov Identifier: NCT02616042     History of Changes
Other Study ID Numbers: CRI09001
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015
Keywords provided by LG Household & Health Care Ltd.:
Centella asiatica
bamboo salt
dentifrice
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases