Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis (MGP)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis: Phase II Study|
- Efficacy of a mouthwash containing 5% propolis for the control of gingivitis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Difference in the Gingival Index scores between the start and the end of the study.
- Efficacy of a mouthwash containing 5% propolis for the control of plaque [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Difference in the Plaque Index scores between the start and the end of the study.
|Study Start Date:||August 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Drug: green propolis mouthwash
- Brazilian propolis
- Baccharis dracunculifolia
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142843
|Universidade Federal de Minas Gerais (UFMG)|
|Belo Horizonte, Minas Gerais, Brazil, 31270-901|