Efficacy of a Mouthwash Containing Propolis (PRO)
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ClinicalTrials.gov Identifier: NCT01750801 |
Recruitment Status
: Unknown
Verified December 2012 by Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais.
Recruitment status was: Not yet recruiting
First Posted
: December 17, 2012
Last Update Posted
: December 17, 2012
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Condition or disease | Intervention/treatment | Phase |
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Gingivitis Periodontitis Plaque Inflammation | Drug: Propolis Drug: chlorhexidine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | February 2013 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Propolis
alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.
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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
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Active Comparator: chlorhexidine
chlorhexidine used on the control of plaque and gingivitis.
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Drug: 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
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- Chemical characterization of propolis by HPLC (High-performance liquid chromatography) [ Time Frame: 8-12 weeks ]
- PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS [ Time Frame: 90 days ]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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750801
Contact: andre oliveira naufel de toledo 35893/MG | 3799668480 | andre_naufel@hotmail.com |
Brazil | |
Federal University of Minas Gerais | |
Belo horizonte, MG, Brazil |
Principal Investigator: | andre oliveira naufel de toledo 35893/MG | UFMG |
Responsible Party: | Andre Oliveira Naufel de Toledo, Principal Investigator, Federal University of Minas Gerais |
ClinicalTrials.gov Identifier: | NCT01750801 History of Changes |
Other Study ID Numbers: |
Propolis |
First Posted: | December 17, 2012 Key Record Dates |
Last Update Posted: | December 17, 2012 |
Last Verified: | December 2012 |
Keywords provided by Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais:
clinical trial mouthwash propolis |
plaque gingivitis compliance |
Additional relevant MeSH terms:
Inflammation Periodontitis Gingivitis Pathologic Processes Periodontal Diseases Mouth Diseases Stomatognathic Diseases Gingival Diseases |
Chlorhexidine Chlorhexidine gluconate Propolis Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents |