Efficacy of a Mouthwash Containing Propolis

NCT ID: NCT01750801

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gingivitis Periodontitis Plaque Inflammation

Keywords

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clinical trial mouthwash propolis plaque gingivitis compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propolis

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

Group Type ACTIVE_COMPARATOR

chlorhexidine

Intervention Type 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

chlorhexidine

chlorhexidine used on the control of plaque and gingivitis.

Group Type ACTIVE_COMPARATOR

Propolis

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Andre Oliveira Naufel de Toledo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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andre oliveira naufel de toledo 35893/MG

Role: PRINCIPAL_INVESTIGATOR

UFMG

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Central Contacts

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andre oliveira naufel de toledo 35893/MG

Role: CONTACT

Phone: 3799668480

Email: [email protected]

Other Identifiers

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Propolis

Identifier Type: -

Identifier Source: org_study_id