Antimicrobial Activity of Two Mouthwashes

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 Overview

• Status: Completed
• Conditions: Periodontal Diseases; Dental Plaque; Caries; Periimplantitis; Oral Surgical Wound Infection
• Intervention / Treatment: Drug: Sterile saline solution; Drug: chlorhexidine; Drug: Polyhexamethylene biguanide

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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.; 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.
EXPERIMENTAL: polyhexamethylene; polyhexamethylene biguanide 0,07% mouthwash	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.; 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (ESTIMATE): March 2, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: chlorhexidine; anti-infective agents; polyhexamethylene biguanide; mouthrinse; local/therapeutic use; dental desinfectants
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Dental Deposits; Surgical Wound; Surgical Wound Infection; Wound Infection; Periodontal Diseases; Peri-Implantitis; Dental Plaque; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine; Polihexanide; Biguanides
• Other Study ID Numbers: MCAS antisseptico oral