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

September 8, 2010 updated by: Federal University of Paraíba

Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58.052-080
        • Recruiting
        • Francisco Campos Statal School
        • Contact:
          • Maria José, Director
          • Phone Number: 558332354184
        • Sub-Investigator:
          • Irlan de Almeida Freires, undergraduate dental student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aroeira
Biological: Use of natural product (Schinus terebinthifolius)
Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammation (Blood gingival index)
Time Frame: baseline
In this time frame will be assessed the initial gingival inflammation in children.
baseline
Plaque amount
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival inflammation (Blood gingival Index)
Time Frame: After 7 days (t1)
In this time frame will be assessed the gingival inflammation in children after 7 days using the product.
After 7 days (t1)
Gingival inflammation (blood gingival index)
Time Frame: After 14 days (t2)
In this time frame will be assessed the final condition of the children after 14 days using the product.
After 14 days (t2)
Plaque amount
Time Frame: After 7 days (t1)
In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).
After 7 days (t1)
Plaque amount
Time Frame: After 14 days (t2)
In this time will be assessed the final oral hygiene condition of the children after 14 days using the product (through the Simplified Oral Hygiene Index).
After 14 days (t2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 2612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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