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
Recruitment status was Recruiting
Sponsor:
Federal University of Paraíba
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
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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 (Child) |
| 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
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 September 30, 2016