Efficacy of a Mouthwash Containing Propolis (PRO)

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.

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

Study Overview

• Status: Unknown
• Conditions: Inflammation; Periodontitis; Gingivitis; Plaque
• Intervention / Treatment: Drug: chlorhexidine; Drug: Propolis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Belo horizonte, MG, Brazil
      • Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ranging from 18 to 60 years
• minimum of 20 natural teeth
• mean plaque index (PI)of at least 1.5
• an average gingival index (GI), at least less than 1.0.

Exclusion Criteria:

• Individuals with orthodontic appliances or removable dentures,
• Individuals whit tumors of soft tissue or hard mouth, and advanced periodontal disease,
• Indivuduals whit antibiotic therapy 2 weeks prior to study initiation, or with known hypersensitivity propolis are also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Propolis; alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.	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
ACTIVE_COMPARATOR: chlorhexidine; chlorhexidine used on the control of plaque and gingivitis.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)	8-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS	After 45 and 90 days using Propolis or chlorhexidine at home, the individuals will return for a clinical evaluation. Alterations in gingival conditions will be analyzed ,both points of comparison products will be based on the Plaque Index of Quigley-Hein and modified gingival index of Loe-Silness modified as scores for the corresponding gravity, being a non-parametric distribution, will be compared by analysis of covariance, by Friedman test for those data to be obtained and analysed the use efficacy after 45 and 90 days.	90 days

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: andre oliveira naufel de toledo 35893/MG, UFMG

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2014
• Study Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (ESTIMATE): December 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: compliance; clinical trial; gingivitis; plaque; propolis; mouthwash
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Inflammation; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine; Propolis
• Other Study ID Numbers: Propolis