Efficacy of a Mouthwash Containing Propolis

Phase 3

• Conditions: Gingivitis; Plaque; Periodontitis; Inflammation
• Interventions: Drug: chlorhexidine; Drug: Propolis

• Registration Number: NCT01750801
• Lead Sponsor: Federal University of Minas Gerais

Brief 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.

Study Timeline

• Study First Submitted: 2012-11-22
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-13
• Last Update Submitted: 2012-12-13
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17
• Study Start: 2013-02
• Primary Completion: 2014-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Propolis	chlorhexidine	alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.
chlorhexidine	Propolis	chlorhexidine used on the control of plaque and gingivitis.

Primary Outcome Measures

Name	Time	Method
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)	8-12 weeks

Secondary Outcome Measures

Name	Time	Method
PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS	90 days	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.

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo horizonte, MG, Brazil