Antimicrobial Activity of Two Mouthwashes

Study Overview
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Brief Summary
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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.

Official Title
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Antimicrobial Activity of Two Mouthwashes

Conditions
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Caries, Periimplantitis, Dental Plaque, Periodontal Diseases, Oral Surgical Wound Infection

Intervention / Treatment
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* Drug: chlorhexidine
* Drug: Polyhexamethylene biguanide
* Drug: Sterile saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 18-30 years Exclusion Criteria: patients with a hypersensitivity or allergic response by some component of the formula antiseptics, pregnant women, lactating, history of periodontal disease, smoking, decompensated diabetics, patients undergoing chemotherapy, radiotherapy patient, transplanted patient and refuses to participate, not signing a term of free and informed concentiment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sterile saline solution<br>sterile Saline solution 0,9% | Drug: Sterile saline solution<br>* 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.<br>|
| Experimental: chlorhexidine<br>chlorhexidine 0,12% mouthwash | Drug: chlorhexidine<br>* 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.<br>Drug: Sterile saline solution<br>* 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.<br>|
| Experimental: polyhexamethylene<br>polyhexamethylene biguanide 0,07% mouthwash | Drug: Polyhexamethylene biguanide<br>* 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.<br>Drug: Sterile saline solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Colony Forming Units | Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes. | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-infective agents, local/therapeutic use, chlorhexidine, dental desinfectants, polyhexamethylene biguanide, mouthrinse