PeriimplantitisNCT02375178
Antimicrobial Activity of Two Mouthwashes
A study testing chlorhexidine, Polyhexamethylene biguanide and Sterile saline solution in people with Periimplantitis and Dental Plaque, run by Universidade do Vale do Sapucai.
Trial summary
This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the oral cavity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis, Dental Plaque, Periodontal Diseases
- What is being tested?
- chlorhexidine, Polyhexamethylene biguanide and Sterile saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients aged 18-30 years
Who cannot join
- patients with a hypersensitivity or allergic response by some component of the formula antiseptics,
- pregnant women,
- lactating,
- history of periodontal disease,
- smoking,
- decompensated diabetics,
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- patients undergoing chemotherapy,
- radiotherapy patient,
- transplanted patient and refuses to participate,
- not signing a term of free and informed concentiment
About this study
This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be processed by a blinded microbiologist.
- Conditions
- Periimplantitis, Dental Plaque, Periodontal Diseases, Caries, Oral Surgical Wound Infection
- Being tested
- chlorhexidine, Polyhexamethylene biguanide, Sterile saline solution
- Keywords
- anti-infective agents, local/therapeutic use, chlorhexidine, dental desinfectants, polyhexamethylene biguanide, mouthrinse
- Medical subject headings
- Peri-Implantitis, Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineDrug
The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0.12% chlorhexidine solution. Samples of saliva will be collected immediately before the mouth wash and after 30, 60 and 180 minutes.
Polyhexamethylene biguanideDrug
The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0,07% solution Polyhexamethylene biguanide. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
Sterile saline solutionDrug
The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of a sterile saline solution. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sterile saline solution | Active comparator | sterile Saline solution 0,9% Receives: Drug: Sterile saline solution |
| chlorhexidine | Experimental | chlorhexidine 0,12% mouthwash Receives: Drug: chlorhexidine; Drug: Sterile saline solution |
| polyhexamethylene | Experimental | polyhexamethylene biguanide 0,07% mouthwash Receives: Drug: Polyhexamethylene biguanide; Drug: Sterile saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Colony Forming Units
Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Sebba de Souza, Universidade do Vale do Sapucai
- Investigators
- Daniela Veiga, MD,PhD, Study chair, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375178
- Sponsor's protocol ID
- MCAS antisseptico oral
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2015
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Activity of Two Mouthwashes
- ClinicalTrials.gov ID
- NCT02375178
- Acronym / sponsor ID
- MCAS antisseptico oral
- Conditions
- Periimplantitis, Dental Plaque, Periodontal Diseases, Caries, Oral Surgical Wound Infection
- Keywords
- anti-infective agents, local/therapeutic use, chlorhexidine, dental desinfectants, polyhexamethylene biguanide, mouthrinse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Mar 2015 (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.
This is a three arm randomized trial. The aim is to evaluate the antimicrobial activity of chlorhexidine and polyhexamethylene biguanide oral antiseptics on the microorganisms of the oral cavity. A total of 30 healthy volunteers will be enrolled and randomly allocated to control group (CG, n=10), which will be instructed to rinse the mouth with 10ml of a sterile saline solution for one minute, to chlorhexidine group (ClG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.12% chlorhexidine solution, for one minute, or to polyhexamethylene biguanide group (PG, n=10), which will be instructed to rinse the mouth with 10ml of an 0.07% polyhexamethylene biguanide solution, for one minute. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. Samples will be plated on manitol agar, mitis salivarius agar, EMB agar and Sabouraud agar. Samples will be processed by a blinded microbiologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sterile saline solution | Active comparator | Drug: Sterile saline solutionsterile Saline solution 0,9% |
| chlorhexidine | Experimental | Drug: chlorhexidine, Drug: Sterile saline solutionchlorhexidine 0,12% mouthwash |
| polyhexamethylene | Experimental | Drug: Polyhexamethylene biguanide, Drug: Sterile saline solutionpolyhexamethylene biguanide 0,07% mouthwash |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients aged 18-30 years
Key exclusion criteria (10 listed)
- patients with a hypersensitivity or allergic response by some component of the formula antiseptics,
- pregnant women,
- lactating,
- history of periodontal disease,
- smoking,
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 |
|---|---|---|
| chlorhexidineThe volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0.12% chlorhexidine solution. Samples of saliva will be collected immediately before the mouth wash and after 30, 60 and 180 minutes. | Drug | chlorhexidine |
| Polyhexamethylene biguanideThe volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0,07% solution Polyhexamethylene biguanide. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. | Drug | polyhexamethylene |
| Sterile saline solutionThe volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of a sterile saline solution. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. | Drug | Sterile saline solution, chlorhexidine, polyhexamethylene |
Primary outcome
Number of Colony Forming Units
Time frame: 180 minutes
Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
Daniela Veiga, MD,PhD study chair
Universidade do Vale do Sapucai
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine, Polyhexamethylene biguanide and Sterile saline solution in people with Periimplantitis and Dental Plaque, run by Universidade do Vale do Sapucai.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Colony Forming Units (time frame: 180 minutes). 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 10 Jan 2017.