Antimicrobial Activity of Two Mouthwashes

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

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	Not Applicable

Study Design

• 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

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Universidade do Vale do Sapucai

Investigators

• Study Chair: Daniela Veiga, MD,PhD; Universidade do Vale do Sapucai

More Information

• 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
• 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:

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