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

Gingivitis Clinical Trial

Official title:

Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01197105
• Other study ID #: ACTG 2612
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: September 7, 2010
• Last updated: September 8, 2010
• Start date: September 2010

Study information

• Verified date: September 2010
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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:

Related Conditions & MeSH terms

• Gingivitis
• Plaque Accumulation

Intervention

Biological:
• Use of natural product (Schinus terebinthifolius)
Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.

Locations

Country	Name	City	State
Brazil	Francisco Campos Statal School	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival inflammation (Blood gingival index)	In this time frame will be assessed the initial gingival inflammation in children.	baseline
Primary	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.	Baseline
Secondary	Gingival inflammation (Blood gingival Index)	In this time frame will be assessed the gingival inflammation in children after 7 days using the product.	After 7 days (t1)
Secondary	Gingival inflammation (blood gingival index)	In this time frame will be assessed the final condition of the children after 14 days using the product.	After 14 days (t2)
Secondary	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).	After 7 days (t1)
Secondary	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).	After 14 days (t2)