Efficacy of a Mouthwash Containing Propolis (PRO)

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ClinicalTrials.gov Identifier: NCT01750801

Recruitment Status : Unknown

Verified December 2012 by Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais.
Recruitment status was: Not yet recruiting

First Posted : December 17, 2012

Last Update Posted : December 17, 2012

Sponsor:

Information provided by (Responsible Party):

Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gingivitis Periodontitis Plaque Inflammation	Drug: Propolis Drug: chlorhexidine	Phase 3

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Participant, 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.
Study Start Date :	February 2013
Estimated Primary Completion Date :	July 2014
Estimated Study Completion Date :	July 2016

Resource links provided by the National Library of Medicine

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

U.S. FDA Resources

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures :

Chemical characterization of propolis by HPLC (High-performance liquid chromatography) [ Time Frame: 8-12 weeks ]

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 ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


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
First Posted:	December 17, 2012 Key Record Dates
Last Update Posted:	December 17, 2012
Last Verified:	December 2012

Keywords provided by Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais:


clinical trial mouthwash propolis	plaque gingivitis compliance

Additional relevant MeSH terms:


Inflammation Periodontitis Gingivitis Pathologic Processes Periodontal Diseases Mouth Diseases Stomatognathic Diseases Gingival Diseases	Chlorhexidine Chlorhexidine gluconate Propolis Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents

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