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

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ClinicalTrials.gov Identifier: NCT01197105
Recruitment Status : Unknown
Verified September 2010 by Federal University of Paraíba.
Recruitment status was:  Recruiting
First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
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.

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

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
Primary Completion Date : September 2010

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



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).



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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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197105


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

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    Key Record Dates
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