Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis (MGP)

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01142843
First received: June 10, 2010
Last updated: July 1, 2010
Last verified: May 2009
  Purpose

Mouthwash based on medicinal plants and propolis can be easily found in the Brazilian market even if it has not been tested in reliable clinical trials on its efficacy or possible unpleasant side effects like the ones which alter the hard and soft oral tissues. The aim of this study was to obtain preliminary evidence of efficacy of an alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Were chosen twenty-five subjects that are UFMG employees and individuals who would begin treatment on an extension project called Supportive Periodontal Therapy at the Faculty of Dentistry of Federal University of Minas Gerais, Belo Horizonte, from August to December 2009. 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. Compliance with the treatment was also evaluated through an attendance form. For the statistic analysis we used BioEstat 4.0 and Excel 2007.


Condition Intervention Phase
Dental Plaque
Gingivitis
Drug: green propolis mouthwash
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Preliminary Evidence of the Efficacy of a Mouthwash Containing 5% Propolis for the Control of Plaque and Gingivitis: Phase II Study

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

Primary Outcome Measures:
  • Efficacy of a mouthwash containing 5% propolis for the control of gingivitis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Difference in the Gingival Index scores between the start and the end of the study.


Secondary Outcome Measures:
  • Efficacy of a mouthwash containing 5% propolis for the control of plaque [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Difference in the Plaque Index scores between the start and the end of the study.


Enrollment: 25
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: green propolis mouthwash
    The subjects were instructed to brush their teeth as usual and to rinse with the 10mL of Mouthwash contain 5% Green Propolis, twice a day, for one minute, right after their meals in the morning and at night. The treatment was performed during three months
    Other Names:
    • mouthrinse
    • Brazilian propolis
    • Baccharis dracunculifolia
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60 years
  • generally good health
  • not pregnant nor breastfeeding
  • a minimum of 20 sound, natural teeth
  • a mean plaque index (PI) (Turesky modification of the Quigley-Hein Plaque Index, 1970) of at least 1.5 or more
  • a mean gingival index (GI) (Talbott modification Gingival Index of the Löe-Silness, 1977) of at least 1.0 or more
  • signing the terms of agreement

Exclusion Criteria:

  • Subjects with orthodontic appliances or removable prosthetics
  • Subjects with tumors of the soft or hard oral tissues
  • Subjects with advanced periodontal disease
  • Subjects that received antibiotic therapy 2 weeks before the start of the study
  • Subjects with hipersensibility to propolis confirmed
  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: NCT01142843

Locations
Brazil
Universidade Federal de Minas Gerais (UFMG)
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais
  More Information

No publications provided

Responsible Party: Vagner Rodrigues Santos, Universidade Federal de Minas Gerais
ClinicalTrials.gov Identifier: NCT01142843     History of Changes
Other Study ID Numbers: VSantos-UFMG
Study First Received: June 10, 2010
Last Updated: July 1, 2010
Health Authority: Brazil: National Agency of Sanitary Monitoring (ANVISA)

Keywords provided by Federal University of Minas Gerais:
clinical trial
mouthwash
green propolis
dental plaque
gingivitis

Additional relevant MeSH terms:
Dental Plaque
Gingivitis
Dental Deposits
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Tooth Diseases
Propolis
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014