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

Study Overview
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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.

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

Conditions
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Gingivitis, Plaque Accumulation

Intervention / Treatment
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* Biological: Use of natural product (Schinus terebinthifolius)


Participation Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival inflammation (Blood gingival Index) | 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) | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, schinus terebinthifolius, natural products