NCT02616042

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 24, 2015

Last Update Submit

November 26, 2015

Conditions

Labor Trial Refused

Keywords

Centella asiaticabamboo saltdentifrice

Outcome Measures

Primary Outcomes (1)

  • Gingivitis

    Gingival index is measured

    Four day

Secondary Outcomes (1)

  • Dental plaque

    Four day

Study Arms (3)

Centella asiatica and bamboo salt

EXPERIMENTAL

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 saltOther: Centella asiatica

Centella asiatica

EXPERIMENTAL

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 saltOther: Centella asiatica

Control dentifrice

PLACEBO COMPARATOR

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 saltOther: Centella asiatica

Interventions

Centella asiatica and bamboo saltOTHER

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 asiaticaCentella asiatica and bamboo saltControl dentifrice
Centella asiaticaOTHER

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.

Centella asiaticaCentella asiatica and bamboo saltControl dentifrice

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemical healthy individual
  • Normal alignment of teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Centella asiatica extractbamboo salt

Study Officials

  • Hyun-Duck Kim, DDS, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 26, 2015

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

November 30, 2015

Record last verified: 2015-11