Efficacy of a Mouthwash Containing Propolis

Inflammation Clinical Trial

— PRO  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01750801
• Other study ID #: Propolis
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 22, 2012
• Last updated: December 13, 2012
• Start date: February 2013
• Est. completion date: July 2016

Study information

• Verified date: December 2012
• Source: Federal University of Minas Gerais
• Contact: andre oliveira naufel de toledo 35893/MG
• Phone: 3799668480
• Email: andre_naufel[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil : ANS
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Periodontitis
• Plaque

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo horizonte	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemical characterization of propolis by HPLC (High-performance liquid chromatography)		8-12 weeks	No
Secondary	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	Yes