Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Mouth Rinses in Regard to Streptococcus Mutans Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598778
Recruitment Status : Unknown
Verified November 2015 by Montefiore Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
Quantitative analysis of change in Salivary Streptococcus Mutans after 30 second oral rinse [ Time Frame: 30 seconds ]
A quantitative analysis of salivary Streptococcus Mutans will be done pre and post 30 second oral rinse
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Mouth Rinses in Regard to Streptococcus Mutans Reduction
Official Title  ICMJE Comparing Chlorhexidine Gluconate, Sodium Fluoride, Coconut Oil and Water Mouth Rinses in Regard to Streptococcus Mutan Reduction
Brief Summary This study compares four mouth rinses in their regard to reducing Streptococcus Mutans after use. The four mouth that will be compared are chlorhexidine gluconate (.12%), sodium fluoride (.05%), coconut oil, and deionized water.
Detailed Description The study is a randomized controlled clinical trial, unblinded. Once consent and assent have been obtained, the participant will be randomly assigned to one of the four mouth rinses being studied. A pre rinse stimulated salivary sample will be taken in which about 3cm of a sterile tongue depressor is introduced into the mouth and turned around 10 times to contaminate it with saliva. Each side of the spatula was then pressed against a petri dish containing Mitis-salivarius agar. The patient will then rinse 10 ml of the assigned rinse for a timed 30 seconds, expectorate, and then a post stimulated salivary sample will be taken similarly to the pre rinse sample. The samples will be transported to a lab for incubation and quantitative analysis of Streptococcus Mutans.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Oral Salivary Streptococcus Mutans Counts
Intervention  ICMJE
  • Drug: Chlorhexidine gluconate (.12%)
    30 second oral rinse of 10mL of solution
    Other Name: Peridex
  • Drug: Sodium Fluoride (.05%)
    30 second oral rinse of 10mL of solution
    Other Name: ACT mouthrinse
  • Other: Coconut Oil
    30 second oral rinse of 10mL of solution
  • Other: Deionized water
    30 second oral rinse of 10mL of solution
Study Arms  ICMJE
  • Active Comparator: Chlorhexidine gluconate (.12%)
    An oral rinse given to pediatric patients in routine practice within the standard of care.
    Intervention: Drug: Chlorhexidine gluconate (.12%)
  • Active Comparator: Sodium fluoride oral rinse (.05%)
    An oral rinse given to pediatric patients in routine practice within the standard of care.
    Intervention: Drug: Sodium Fluoride (.05%)
  • Active Comparator: Coconut oil
    A food product. In previous studies it has shown positive effects on the reduction of oral plaque and gingivitis as an oral rinse.
    Intervention: Other: Coconut Oil
  • Placebo Comparator: Deionized water
    Water that has had the majority of its ions removed.
    Intervention: Other: Deionized water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 5, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients presenting to the dental clinic for routine dental treatment (including recall exams, new patient exams, and operative appointments) who are ASA class I or II, cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating Scale,
  • No known allergies or sensitivities to products or ingredients being tested

Exclusion Criteria:

  • ASA III or above
  • Known allergies or sensitivities to any of the mouth rinses or any of the ingredients in the mouth rinses to be tested
  • Non English speaking parent or participant
  • Patient presenting to the clinic as a walk in or emergency appointment
  • Patient experiencing any pain or sensitivity
  • consuming any beverage or food or performing oral hygiene practices such as brushing or flossing, within 1 hour prior to trial participation
  • No use of a mouth rinse in the last 24 hours
  • Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to the Frankl Behavioral Rating Scale
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598778
Other Study ID Numbers  ICMJE 2015-5583
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nuntiya Kakanantadilok, DMD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP