Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
Primary Purpose
Gingivitis, Plaque Accumulation
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Use of natural product (Schinus terebinthifolius)
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring gingivitis, schinus terebinthifolius, natural products
Eligibility Criteria
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:
-
Sites / Locations
- Francisco Campos Statal SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aroeira
Arm Description
Outcomes
Primary Outcome Measures
Gingival inflammation (Blood gingival index)
In this time frame will be assessed the initial gingival inflammation in children.
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.
Secondary Outcome Measures
Gingival inflammation (Blood gingival Index)
In this time frame will be assessed the gingival inflammation in children after 7 days using the product.
Gingival inflammation (blood gingival index)
In this time frame will be assessed the final condition of the children after 14 days using the product.
Plaque amount
In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).
Plaque amount
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).
Full Information
NCT ID
NCT01197105
First Posted
September 7, 2010
Last Updated
September 8, 2010
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT01197105
Brief Title
Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
Official Title
Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Paraíba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque Accumulation
Keywords
gingivitis, schinus terebinthifolius, natural products
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aroeira
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Use of natural product (Schinus terebinthifolius)
Intervention Description
Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.
Primary Outcome Measure Information:
Title
Gingival inflammation (Blood gingival index)
Description
In this time frame will be assessed the initial gingival inflammation in children.
Time Frame
baseline
Title
Plaque amount
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Gingival inflammation (Blood gingival Index)
Description
In this time frame will be assessed the gingival inflammation in children after 7 days using the product.
Time Frame
After 7 days (t1)
Title
Gingival inflammation (blood gingival index)
Description
In this time frame will be assessed the final condition of the children after 14 days using the product.
Time Frame
After 14 days (t2)
Title
Plaque amount
Description
In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).
Time Frame
After 7 days (t1)
Title
Plaque amount
Description
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).
Time Frame
After 14 days (t2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Francisco Campos Statal School
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58.052-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria José, Director
Phone
558332354184
First Name & Middle Initial & Last Name & Degree
Irlan de Almeida Freires, undergraduate dental student
12. IPD Sharing Statement
Citations:
PubMed Identifier
14076341
Citation
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.
Results Reference
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Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
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