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Antimicrobial Activity of Two Mouthwashes

Primary Purpose

Periimplantitis, Dental Plaque, Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

chlorhexidine

Polyhexamethylene biguanide

Sterile saline solution

About this trial

This is an interventional prevention trial for Periimplantitis focused on measuring anti-infective agents, local/therapeutic use, chlorhexidine, dental desinfectants, polyhexamethylene biguanide, mouthrinse

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Sterile saline solution

chlorhexidine

polyhexamethylene

Arm Description

sterile Saline solution 0,9%

chlorhexidine 0,12% mouthwash

polyhexamethylene biguanide 0,07% mouthwash

Outcomes

Primary Outcome Measures

Number of Colony Forming Units

Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.

Secondary Outcome Measures

Full Information

NCT ID

NCT02375178

First Posted

February 24, 2015

Last Updated

January 9, 2017

Sponsor

Universidade do Vale do Sapucai

1. Study Identification

Unique Protocol Identification Number

NCT02375178

Brief Title

Antimicrobial Activity of Two Mouthwashes

Official Title

Antimicrobial Activity of Two Mouthwashes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade do Vale do Sapucai

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periimplantitis, Dental Plaque, Periodontal Diseases, Caries, Oral Surgical Wound Infection

Keywords

anti-infective agents, local/therapeutic use, chlorhexidine, dental desinfectants, polyhexamethylene biguanide, mouthrinse

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sterile saline solution

Arm Type

Active Comparator

Arm Description

sterile Saline solution 0,9%

Arm Title

chlorhexidine

Arm Type

Experimental

Arm Description

chlorhexidine 0,12% mouthwash

Arm Title

polyhexamethylene

Arm Type

Experimental

Arm Description

polyhexamethylene biguanide 0,07% mouthwash

Intervention Type

Drug

Intervention Name(s)

chlorhexidine

Intervention Description

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

Intervention Name(s)

Polyhexamethylene biguanide

Intervention Description

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

Intervention Name(s)

Sterile saline solution

Intervention Description

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 Measure Information:

Title

Number of Colony Forming Units

Description

Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.

Time Frame

180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Veiga, MD,PhD

Organizational Affiliation

Universidade do Vale do Sapucai

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Antimicrobial Activity of Two Mouthwashes

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