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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Federal University of Paraíba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of Paraíba
ClinicalTrials.gov Identifier:
NCT01197105
First received: September 7, 2010
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Gingivitis
Plaque Accumulation
Biological: Use of natural product (Schinus terebinthifolius)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis

Further study details as provided by Federal University of Paraíba:

Primary Outcome Measures:
  • Gingival inflammation (Blood gingival index) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    In this time frame will be assessed the initial gingival inflammation in children.

  • Plaque amount [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Gingival inflammation (Blood gingival Index) [ Time Frame: After 7 days (t1) ] [ Designated as safety issue: No ]
    In this time frame will be assessed the gingival inflammation in children after 7 days using the product.

  • Gingival inflammation (blood gingival index) [ Time Frame: After 14 days (t2) ] [ Designated as safety issue: No ]
    In this time frame will be assessed the final condition of the children after 14 days using the product.

  • Plaque amount [ Time Frame: After 7 days (t1) ] [ Designated as safety issue: No ]
    In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).

  • Plaque amount [ Time Frame: After 14 days (t2) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 60
Study Start Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aroeira Biological: Use of natural product (Schinus terebinthifolius)
Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: September 7, 2010
Last Updated: September 8, 2010
Health Authority: Brazil: Ethics Committee
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014