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Antimicrobial Activity of Two Mouthwashes

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ClinicalTrials.gov Identifier: NCT02375178
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Fernanda Sebba de Souza, Universidade do Vale do Sapucai

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2015


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02375178


Sponsors and Collaborators
Universidade do Vale do Sapucai
Investigators
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Study Chair: Daniela Veiga, MD,PhD Universidade do Vale do Sapucai
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Responsible Party: Fernanda Sebba de Souza, student, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT02375178    
Other Study ID Numbers: MCAS antisseptico oral
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Fernanda Sebba de Souza, Universidade do Vale do Sapucai:
anti-infective agents
local/therapeutic use
chlorhexidine
dental desinfectants
polyhexamethylene biguanide
mouthrinse
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Periodontal Diseases
Dental Plaque
Peri-Implantitis
Surgical Wound
Mouth Diseases
Stomatognathic Diseases
Infections
Wounds and Injuries
Dental Deposits
Tooth Diseases
Postoperative Complications
Pathologic Processes
Biguanides
Chlorhexidine
Polihexanide
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Hypoglycemic Agents
Physiological Effects of Drugs