GingivitisPhase 3PRONCT01750801
Efficacy of a Mouthwash Containing Propolis
A Phase 3 study testing Propolis and chlorhexidine in people with Gingivitis and Periodontitis, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis, Plaque
- What is being tested?
- Propolis and chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I.
Read the 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.
- Conditions
- Gingivitis, Periodontitis, Plaque, Inflammation
- Being tested
- Propolis, chlorhexidine
- Keywords
- clinical trial, mouthwash, propolis, plaque, gingivitis, compliance
- Medical subject headings
- Gingivitis, Periodontitis, Plaque, Amyloid, Inflammation, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDrug
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
chlorhexidineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Active comparator | alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. Receives: Drug: chlorhexidine |
| chlorhexidine | Active comparator | chlorhexidine used on the control of plaque and gingivitis. Receives: Drug: Propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
Measured: 8-12 weeks
Secondary outcomes (1)
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Oliveira Naufel de Toledo, Federal University of Minas Gerais
- Investigators
- andre oliveira naufel de toledo 35893/MG, Principal investigator, UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750801
- Sponsor's protocol ID
- Propolis
- Acronym
- PRO
- Status last verified
- Dec 2012
- First submitted
- 22 Nov 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01750801
- Acronym / sponsor ID
- PRO / Propolis
- Conditions
- Gingivitis, Periodontitis, Plaque, Inflammation
- Keywords
- clinical trial, mouthwash, propolis, plaque, gingivitis, compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis | Active comparator | Drug: chlorhexidinealcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis. |
| chlorhexidine | Active comparator | Drug: Propolischlorhexidine used on the control of plaque and gingivitis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropolisTwenty-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 | Drug | chlorhexidine |
| chlorhexidineTwenty-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 | Drug | Propolis |
Primary outcome
Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
Time frame: 8-12 weeks
1 secondary outcome
PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Related trials for Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
andre oliveira naufel de toledo 35893/MG principal investigator
UFMG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propolis and chlorhexidine in people with Gingivitis and Periodontitis, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact andre oliveira naufel de toledo 35893/MG (3799668480, andre_naufel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemical characterization of propolis by HPLC (High-performance liquid chromatography) (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.