Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis (MGP)
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ClinicalTrials.gov Identifier: NCT01142843
Recruitment Status :
First Posted : June 11, 2010
Last Update Posted : July 2, 2010
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Mouthwash based on medicinal plants and propolis can be easily found in the Brazilian market even if it has not been tested in reliable clinical trials on its efficacy or possible unpleasant side effects like the ones which alter the hard and soft oral tissues. The aim of this study was to obtain preliminary evidence of efficacy of an alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Were chosen twenty-five subjects that are UFMG employees and individuals who would begin treatment on an extension project called Supportive Periodontal Therapy at the Faculty of Dentistry of Federal University of Minas Gerais, Belo Horizonte, from August to December 2009. The subjects went through a dental prophylaxis before starting rinse. They were then instructed to rinse twice a day for a minute, immediately after brushing (morning and night), using the 10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a clinical evaluation which considered changes in the soft and hard oral tissues and involved collecting plaque and gingivitis indexes. On their last appointment the subjects answered a questionnaire about their level of appreciation and acceptability of the mouthwash. Compliance with the treatment was also evaluated through an attendance form. For the statistic analysis we used BioEstat 4.0 and Excel 2007.
The subjects were instructed to brush their teeth as usual and to rinse with the 10mL of Mouthwash contain 5% Green Propolis, twice a day, for one minute, right after their meals in the morning and at night. The treatment was performed during three months
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
age 18-60 years
generally good health
not pregnant nor breastfeeding
a minimum of 20 sound, natural teeth
a mean plaque index (PI) (Turesky modification of the Quigley-Hein Plaque Index, 1970) of at least 1.5 or more
a mean gingival index (GI) (Talbott modification Gingival Index of the Löe-Silness, 1977) of at least 1.0 or more
signing the terms of agreement
Subjects with orthodontic appliances or removable prosthetics
Subjects with tumors of the soft or hard oral tissues
Subjects with advanced periodontal disease
Subjects that received antibiotic therapy 2 weeks before the start of the study
Subjects with hipersensibility to propolis confirmed