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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Gingivitis; Plaque Accumulation	Biological: Use of natural product (Schinus terebinthifolius)	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis
Study Start Date :	September 2010
Actual Primary Completion Date :	September 2010

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Gingival inflammation (Blood gingival index) [ Time Frame: baseline ]
   In this time frame will be assessed the initial gingival inflammation in children.
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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).
4. 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).

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Federal University of Paraíba

More Information

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Publications:

LÖE H. The Gingival index, the plaque index and the retention index systems. J Periodontol (Chicago), v.38, n.6, p. 610-4, 1967. GREENE, J. C. ; VERMILLION, J. R. The simplified oral hygiene index. J. Amer. Dent. Assoc., v.68, p.7-13, 1964.

Responsible Party:	Ricardo Dias de Castro, Federal University of Paraiba
ClinicalTrials.gov Identifier:	NCT01197105 History of Changes
Other Study ID Numbers:	ACTG 2612
First Posted:	September 9, 2010
Last Update Posted:	September 9, 2010
Last Verified:	September 2010

Keywords provided by Federal University of Paraíba:

gingivitis; schinus terebinthifolius; natural products

Additional relevant MeSH terms:

Gingivitis; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases