Antimicrobial Activity of Two Mouthwashes

Periodontal Diseases Clinical Trial

Official title:

Antimicrobial Activity of Two Mouthwashes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375178
• Other study ID #: MCAS antisseptico oral
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: January 9, 2017
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries
• Dental Plaque
• Gingival Diseases
• Oral Surgical Wound Infection
• Peri-Implantitis
• Periimplantitis
• Periodontal Diseases
• Surgical Wound Infection
• Wound Infection

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Colony Forming Units	Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.	180 minutes	No