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Efficacy of a Mouthwash Containing Propolis (PRO)

Primary Purpose

Gingivitis, Periodontitis, Plaque

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Propolis
chlorhexidine
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring clinical trial, mouthwash, propolis, plaque, gingivitis, compliance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propolis

chlorhexidine

Arm Description

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

chlorhexidine used on the control of plaque and gingivitis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2012
Last Updated
December 13, 2012
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01750801
Brief Title
Efficacy of a Mouthwash Containing Propolis
Acronym
PRO
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis, Plaque, Inflammation
Keywords
clinical trial, mouthwash, propolis, plaque, gingivitis, compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propolis
Arm Type
Active Comparator
Arm Description
alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.
Arm Title
chlorhexidine
Arm Type
Active Comparator
Arm Description
chlorhexidine used on the control of plaque and gingivitis.
Intervention Type
Drug
Intervention Name(s)
Propolis
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
chlorhexidine
Intervention Description
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
Primary Outcome Measure Information:
Title
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
andre oliveira naufel de toledo 35893/MG
Phone
3799668480
Email
andre_naufel@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
andre oliveira naufel de toledo 35893/MG
Organizational Affiliation
UFMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo horizonte
State/Province
MG
Country
Brazil

12. IPD Sharing Statement

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Efficacy of a Mouthwash Containing Propolis

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