Efficacy of a Mouthwash Containing Propolis (PRO)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified December 2012 by Federal University of Minas Gerais

Sponsor:

Information provided by (Responsible Party):

Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais

ClinicalTrials.gov Identifier:

NCT01750801

First received: November 22, 2012

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Gingivitis Periodontitis Plaque Inflammation	Drug: Propolis Drug: chlorhexidine	Phase 3


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

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Chlorhexidine acetate Chlorhexidine hydrochloride Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:

Chemical characterization of propolis by HPLC (High-performance liquid chromatography) [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	2
Study Start Date:	February 2013
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: chlorhexidine
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 Other Name: Propolis

Arms

Assigned Interventions

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

Other Name: chlorhexidine

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

Other Name: 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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750801

Contacts


Contact: andre oliveira naufel de toledo 35893/MG	3799668480	andre_naufel@hotmail.com

Locations


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

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators


Principal Investigator:	andre oliveira naufel de toledo 35893/MG	UFMG

More Information

No publications provided


Responsible Party:	Andre Oliveira Naufel de Toledo, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:	NCT01750801 History of Changes
Other Study ID Numbers:	Propolis
Study First Received:	November 22, 2012
Last Updated:	December 13, 2012
Health Authority:	Brazil : ANS

Keywords provided by Federal University of Minas Gerais:


clinical trial mouthwash propolis	plaque gingivitis compliance

Additional relevant MeSH terms:


Gingival Diseases Gingivitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases Chlorhexidine Chlorhexidine gluconate	Propolis Anti-Infective Agents Anti-Infective Agents, Local Dermatologic Agents Disinfectants Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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