Antimicrobial Activity of Two Mouthwashes

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT02375178

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Periimplantitis Dental Plaque Periodontal Diseases Caries Oral Surgical Wound Infection	Drug: chlorhexidine Drug: Polyhexamethylene biguanide Drug: Sterile saline solution	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Antimicrobial Activity of Two Mouthwashes

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sterile saline solution sterile Saline solution 0,9%	Drug: Sterile saline solution 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.
Experimental: chlorhexidine chlorhexidine 0,12% mouthwash	Drug: chlorhexidine 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. Drug: Sterile saline solution 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.
Experimental: polyhexamethylene polyhexamethylene biguanide 0,07% mouthwash	Drug: Polyhexamethylene biguanide 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. Drug: Sterile saline solution 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.

Arm

Intervention/Treatment

Active Comparator: Sterile saline solution

sterile Saline solution 0,9%

Drug: Sterile saline solution

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.

Experimental: chlorhexidine

chlorhexidine 0,12% mouthwash

Drug: chlorhexidine

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.

Drug: Sterile saline solution

Experimental: polyhexamethylene

polyhexamethylene biguanide 0,07% mouthwash

Drug: Polyhexamethylene biguanide

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.

Drug: Sterile saline solution

Outcome Measures

Primary Outcome Measures

Number of Colony Forming Units [180 minutes]
Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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