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
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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 |
Actual 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.
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- Gingival inflammation (Blood gingival index) [ Time Frame: baseline ]In this time frame will be assessed the initial gingival inflammation in children.
- 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.
- 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.
- 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.
- 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).
- 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 |
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:

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
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 |
Publications:
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 |