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Status unknownNCT01197105Updated Sep 9, 2010

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

A Phase 1/2 interventional study of Use of natural product (Schinus terebinthifolius) in Gingivitis and Plaque Accumulation, sponsored by Federal University of Paraíba. Status unknown at 1 site in Brazil. Open to participants aged 10 Years to 12 Years. Per ClinicalTrials.gov, last updated 2010-09-09.

Sponsored by Federal University of Paraíba · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gingivitis
  • Plaque Accumulation

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Keywords

  • gingivitis
  • schinus terebinthifolius
  • natural products
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Federal University of Paraíba is the lead sponsor of 72 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Aroeira

    Biological: Use of natural product (Schinus terebinthifolius)

Interventions

  • BiologicalUse of natural product (Schinus terebinthifolius)

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

06

What researchers measure

Primary outcomes

  1. Gingival inflammation (Blood gingival index)

    In this time frame will be assessed the initial gingival inflammation in children.

    Time frame: baseline

  2. 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.

    Time frame: Baseline

Secondary outcomes

  1. Gingival inflammation (Blood gingival Index)

    In this time frame will be assessed the gingival inflammation in children after 7 days using the product.

    Time frame: After 7 days (t1)

  2. Gingival inflammation (blood gingival index)

    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)

  3. 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).

    Time frame: After 7 days (t1)

  4. 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).

    Time frame: After 14 days (t2)

07

Study locations

1 of 1 sites recruiting
  • Francisco Campos Statal School
    João Pessoa, Paraíba 58.052-080, Brazil
    • Maria José, Director · Contact · 558332354184
    • Irlan de Almeida Freires, undergraduate dental student · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 14076341 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01197105
Lead sponsor
Federal University of Paraíba
First posted
Sep 9, 2010
Start date
Sep 2010
Primary completion
Sep 2010
Last update
Sep 9, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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