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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197105

Enrollment

Registered

2010-09-09

Start date

2010-09-30

Completion date

Unknown

Last updated

2010-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Plaque Accumulation

Keywords

gingivitis, schinus terebinthifolius, natural products

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.

Interventions

BIOLOGICALUse of natural product (Schinus terebinthifolius)

Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026