Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children

NCT ID: NCT01197105

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gingivitis Plaque Accumulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aroeira

Group Type EXPERIMENTAL

Use of natural product (Schinus terebinthifolius)

Intervention Type BIOLOGICAL

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

Interventions

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Use of natural product (Schinus terebinthifolius)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Paraiba

Locations

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Francisco Campos Statal School

João Pessoa, Paraíba, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Maria José, Director

Role: primary

558332354184

References

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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.

Reference Type BACKGROUND
PMID: 14076341 (View on PubMed)

Other Identifiers

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ACTG 2612

Identifier Type: -

Identifier Source: org_study_id