NCT01750801

Efficacy of a Mouthwash Containing Propolis

Clinical Evidence Efficacy of a Mouthwash Containing Propolis for the Control of Plaque and Gingivitis: Phase III, Randomized, Double-blind Comparison With Mouthwash Chlorhexidine Base.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I.

Detailed description

Chemical characterization of propolis by HPLC (High-performance liquid chromatography), antimicrobial testing against pathogens and cariogenic. Studies in vitro on anti-inflammatory activity, cytotoxicity tests of green propolis.

Conditions

• Gingivitis
• Periodontitis
• Plaque
• Inflammation

Interventions

Type	Name	Description
DRUG	Propolis	Twenty-five subjects, both male and female, were chosen after signing the terms of agreement.. The criteria for selection stated that subjects should be from 18 to 60 years old, should present good health, a minimum of 20 teeth and not be pregnant or breastfeeding.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
DRUG	chlorhexidine	Twenty-five subjects, both male and female, were chosen after signing the terms of agreement.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

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-07-01
• Completion: 2016-07-01
• First posted: 2012-12-17
• Last updated: 2012-12-17

Locations

1 site across 1 country: Brazil