Efficacy of a Mouthwash Containing Propolis

NCT01750801 | Unknown Phase 3

• 1 other identifier: Propolis
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingivitis; Periodontitis; Plaque; Inflammation

Keywords

clinical trial; mouthwash; propolis; plaque; gingivitis; compliance

Outcome Measures

Primary Outcomes (1)

• Chemical characterization of propolis by HPLC (High-performance liquid chromatography)

  8-12 weeks

Secondary Outcomes (1)

• PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS

  90 days

Study Arms (2)

Propolis

ACTIVE COMPARATOR

alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.

Drug: chlorhexidine

chlorhexidine

ACTIVE COMPARATOR

chlorhexidine used on the control of plaque and gingivitis.

Drug: Propolis

Interventions

Propolis DRUG

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

chlorhexidine DRUG

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

Propolis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Gingivitis; Periodontitis; Plaque, Amyloid; Inflammation; Patient Compliance

Interventions

Propolis; Chlorhexidine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• andre oliveira naufel de toledo 35893/MG

  UFMG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

andre oliveira naufel de toledo 35893/MG

CONTACT

3799668480; andre_naufel@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 17, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

BR (1)