Antimicrobial Activity of Two Mouthwashes

Not Applicable

Completed

• Conditions: Dental Plaque; Periodontal Diseases; Periimplantitis; Caries; Oral Surgical Wound Infection
• Interventions: Drug: chlorhexidine; Drug: Polyhexamethylene biguanide; Drug: Sterile saline solution

• Registration Number: NCT02375178
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-10
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorhexidine	Sterile saline solution	chlorhexidine 0,12% mouthwash
Sterile saline solution	Sterile saline solution	sterile Saline solution 0,9%
polyhexamethylene	Sterile saline solution	polyhexamethylene biguanide 0,07% mouthwash
chlorhexidine	chlorhexidine	chlorhexidine 0,12% mouthwash
polyhexamethylene	Polyhexamethylene biguanide	polyhexamethylene biguanide 0,07% mouthwash

Primary Outcome Measures

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