NCT01197105

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

September 7, 2010

Last Update Submit

September 8, 2010

Conditions

GingivitisPlaque Accumulation

Keywords

gingivitisschinus terebinthifoliusnatural products

Outcome Measures

Primary Outcomes (2)

  • Gingival inflammation (Blood gingival index)

    In this time frame will be assessed the initial gingival inflammation in children.

    baseline

  • Plaque amount

    In this time will be assessed the initial oral hygiene condition of the children before the use of the product through the Simplified Oral Hygiene Index.

    Baseline

Secondary Outcomes (4)

  • Gingival inflammation (Blood gingival Index)

    After 7 days (t1)

  • Gingival inflammation (blood gingival index)

    After 14 days (t2)

  • Plaque amount

    After 7 days (t1)

  • Plaque amount

    After 14 days (t2)

Study Arms (1)

Aroeira

EXPERIMENTAL
Biological: Use of natural product (Schinus terebinthifolius)

Interventions

Use of natural product (Schinus terebinthifolius)BIOLOGICAL

Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.

Aroeira

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group: 10-12 years old
  • Presence of at least 20 dental elements
  • Do not use orthodontic fixed appliances
  • Simplified Oral Hygiene Index (S-OHI) is greater than 2
  • Levels of Microbiological Streptococcus mutans in saliva high (\> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)
  • Susceptibility to form biofilm and gingival inflammation
  • Absence of systemic disease
  • Not be under the use of antiseptic mouthwash in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Campos Statal School

João Pessoa, Paraíba, 58.052-080, Brazil

RECRUITING

Related Publications (1)

  • GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

    PMID: 14076341BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations

BR(1)