Clinical Evidence of the Efficacy of a Mouthwash Containing Propolis for the Control of Plaque and Gingivitis: A Phase II Study.

The aim of this study was to evidence the clinical efficacy of an alcohol-free mouthwash containing 5.0% (W/V) Brazilian green propolis (MGP 5%) for the control of plaque and gingivitis. Twenty five subjects, men and women aging between 18 and 60 years old (35 ± 9), were included in a clinical trials phase II study who had a minimum of 20 sound natural teeth, a mean plaque index of at least 1.5 (PI), and a mean gingival index of at least 1.0 (GI). They were instructed to rinse with 10 mL of mouthwash test for 1 minute, immediately after brushing in the morning and at night. After 45 and 90 days using mouthwash, the results showed a significant reduction in plaque and in gingival index when compared to samples obtained in baseline. These reductions were at 24% and 40%, respectively (P < .5). There were no important side effects in soft and hard tissues of the mouth. In this study, the MGP 5% showed evidence of its efficacy in reducing PI and GI. However, it is necessary to perform a clinical trial, double-blind, randomized to validate such effectiveness.

Phase II study with mounthrinse containing 5% of propolis for three-months: compliance, appreciation and acceptability of the product / Estudo fase II com colutório contendo própolis 5%: aderência, apreciação e aceitabilidade do produto

A placa dentária é considerada um fator etiológico chave associado a gengivite decorrente. A sua remoção pode ser difícil em pacientes que possuam coordenação motora deficiente ou quaisquer outros problemas. Então, ouso do bochecho como adjunto da escovação no controle da placa bacteriana e da gengivite pode aumentar os benefícios no controle de placa dental. Um estudo de fase II foi utilizado para avaliar a aderência, a apreciação e a aceitabilidade de um enxaguatório bucal sem álcool contendo 5% de própolis verde (EPV 5%) no controle de placa e gengivite durante três meses. Cada indivíduo, ao final do estudo, respondeu a um questionário sobre a apreciação e aceitabilidade do enxaguante bucal. Vinte e um pacientes completaram o estudo, apesar de a maioria deles terem considerado o sabor do EPV 5% desagradável. Eles ficaram satisfeitos com o produto e apontaram as mudanças positivas na saúde bucal após o período de tratamento. Sendo assim, a adesão foi satisfatória (≥80%) sem diferença estatisticamente significante entre os períodos de bochecho da manhã da noite.

Dental plaque is considered a key etiological factor associated with arising gingivitis. Its removal can be difficult in pacients with lack of coordination or any other problems. Then, the use of mouthrinse as adjunct to toothbrushing in control of plaque and gingivitis might increase the benefits of controlling dental plaque. A phase II study was used to evaluate the compliance, appreciation and acceptability of an alcohol-free mouthwash contain 5% green propolis (MGP 5%) in control of plaque and gingivitis for three months. Each subject, at the end of the study, answered a questionnaire about appreciation and acceptance of the mouthwash. Twenty one subjects completed the study, although most of them felt the taste of MGP 5% unpleasant. They were satisfied with the product, pointing positive changes in the oral health after the treatment period. Then, the compliance was satisfactory (≥ 80%) with no statistically significant difference between the periods of rinsing in the morning and at night