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

NCT02616042 — Phase 3, Completed, 33 participants, LG Household & Health Care Ltd.

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

RegistryNCT02616042
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, crossover, masking: quadruple, prevention
Enrollment33 (Actual)
SponsorLG Household & Health Care Ltd. (Industry); collaborators: Seoul National University
ConditionsLabor Trial Refused
InterventionsCentella asiatica and bamboo salt, Centella asiatica (Other)
Datesstart 2009-03-01, primary completion 2009-07-01, completion 2009-12-01, first posted 2015-11-26, last updated 2015-11-30

Related Papers Related Patents Related Grants Related Experts
All trials for Labor Trial Refused All trials of Centella asiatica and bamboo salt All trials of Centella asiatica

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Centella asiatica and bamboo saltExperimentalOther: Centella asiatica and bamboo salt; Other: Centella asiaticaParticipants 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.
Centella asiaticaExperimentalOther: Centella asiatica and bamboo salt; Other: Centella asiaticaParticipants 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).
Control dentifricePlacebo comparatorOther: Centella asiatica and bamboo salt; Other: Centella asiaticaParticipants 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).
  • Centella asiatica and bamboo salt (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 (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.

+Outcome measures

Primary outcomes

  • Gingivitis [Four day]: Gingival index is measured

Secondary outcomes

  • Dental plaque [Four day]: Plaque index is measured

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

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

+Investigators