Antimicrobial Activity of Two Mouthwashes

NCT ID: NCT02375178

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Periimplantitis Dental Plaque Periodontal Diseases Caries Oral Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sterile saline solution

sterile Saline solution 0,9%

Group Type ACTIVE_COMPARATOR

Sterile saline solution

Intervention Type DRUG

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.

chlorhexidine

chlorhexidine 0,12% mouthwash

Group Type EXPERIMENTAL

chlorhexidine

Intervention Type DRUG

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.

Sterile saline solution

Intervention Type DRUG

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.

polyhexamethylene

polyhexamethylene biguanide 0,07% mouthwash

Group Type EXPERIMENTAL

Polyhexamethylene biguanide

Intervention Type DRUG

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.

Sterile saline solution

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Sebba de Souza

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Veiga, MD,PhD

Role: STUDY_CHAIR

Universidade do Vale do Sapucai

Other Identifiers

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MCAS antisseptico oral

Identifier Type: -

Identifier Source: org_study_id

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