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

Phase 1

• Conditions: Gingivitis; Plaque Accumulation

• Registration Number: NCT01197105
• Lead Sponsor: Federal University of Paraíba

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Primary Completion: 2010-09
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Last Update Submitted: 2010-09-08
• Study First Posted: 2010-09-09
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Gingival inflammation (Blood gingival index)	baseline	In this time frame will be assessed the initial gingival inflammation in children.
Plaque amount	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

Name	Time	Method
Gingival inflammation (Blood gingival Index)	After 7 days (t1)	In this time frame will be assessed the gingival inflammation in children after 7 days using the product.
Gingival inflammation (blood gingival index)	After 14 days (t2)	In this time frame will be assessed the final condition of the children after 14 days using the product.
Plaque amount	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).

Trial Locations

Locations (1)

Francisco Campos Statal School; 🇧🇷 João Pessoa, Paraíba, Brazil