NCT02375178

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

February 24, 2015

Last Update Submit

January 9, 2017

Conditions

PeriimplantitisDental PlaquePeriodontal DiseasesCariesOral Surgical Wound Infection

Keywords

anti-infective agentslocal/therapeutic usechlorhexidinedental desinfectantspolyhexamethylene biguanidemouthrinse

Outcome Measures

Primary Outcomes (1)

  • Number of Colony Forming Units

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

    180 minutes

Study Arms (3)

Sterile saline solution

ACTIVE COMPARATOR

sterile Saline solution 0,9%

Drug: Sterile saline solution

chlorhexidine

EXPERIMENTAL

chlorhexidine 0,12% mouthwash

Drug: chlorhexidineDrug: Sterile saline solution

polyhexamethylene

EXPERIMENTAL

polyhexamethylene biguanide 0,07% mouthwash

Drug: Polyhexamethylene biguanideDrug: Sterile saline solution

Interventions

chlorhexidineDRUG

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.

chlorhexidine
Polyhexamethylene biguanideDRUG

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.

polyhexamethylene
Sterile saline solutionDRUG

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.

Sterile saline solutionchlorhexidinepolyhexamethylene

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged 18-30 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peri-ImplantitisDental PlaquePeriodontal Diseases

Interventions

Chlorhexidinepolihexanide

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Daniela Veiga, MD,PhD

    Universidade do Vale do Sapucai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2015

Last Updated

January 10, 2017

Record last verified: 2017-01