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

NCT01142843 | Completed Phase 2 DMC

• 1 other identifier: VSantos-UFMG
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Plaque; Gingivitis

Keywords

clinical trial; mouthwash; green propolis; dental plaque; gingivitis

Outcome Measures

Primary Outcomes (1)

• Efficacy of a mouthwash containing 5% propolis for the control of gingivitis

  Difference in the Gingival Index scores between the start and the end of the study.

  90 days

Secondary Outcomes (1)

• Efficacy of a mouthwash containing 5% propolis for the control of plaque

  90 days

Interventions

green propolis mouthwash DRUG

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

Also known as: mouthrinse, Brazilian propolis, Baccharis dracunculifolia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Universidade Federal de Minas Gerais (UFMG)

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: July 2, 2010

Record last verified: 2009-05

Locations

BR (1)