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Trial record 21 of 259 for:    sodium fluoride

Comparing Mouth Rinses in Regard to Streptococcus Mutans Reduction

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2015 by Montefiore Medical Center
Information provided by (Responsible Party):
Montefiore Medical Center Identifier:
First received: November 4, 2015
Last updated: November 5, 2015
Last verified: November 2015
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.

Condition Intervention
Oral Salivary Streptococcus Mutans Counts
Drug: Chlorhexidine gluconate (.12%)
Drug: Sodium Fluoride (.05%)
Other: Coconut Oil
Other: Deionized water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparing Chlorhexidine Gluconate, Sodium Fluoride, Coconut Oil and Water Mouth Rinses in Regard to Streptococcus Mutan Reduction

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Quantitative analysis of change in Salivary Streptococcus Mutans after 30 second oral rinse [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
    A quantitative analysis of salivary Streptococcus Mutans will be done pre and post 30 second oral rinse

Estimated Enrollment: 40
Study Start Date: November 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine gluconate (.12%)
An oral rinse given to pediatric patients in routine practice within the standard of care.
Drug: Chlorhexidine gluconate (.12%)
30 second oral rinse of 10mL of solution
Other Name: Peridex
Active Comparator: Sodium fluoride oral rinse (.05%)
An oral rinse given to pediatric patients in routine practice within the standard of care.
Drug: Sodium Fluoride (.05%)
30 second oral rinse of 10mL of solution
Other Name: ACT mouthrinse
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.
Other: Coconut Oil
30 second oral rinse of 10mL of solution
Placebo Comparator: Deionized water
Water that has had the majority of its ions removed.
Other: Deionized water
30 second oral rinse of 10mL of solution

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.

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02598778

Contact: Jessica Mattern, DDS 4807940302
Contact: Janna Danbe, DMD

United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Nuntiya Kakanantadilok, DMD    718-920-1740 ext 2135      
Contact: Jessica Mattern, DDS    4807940302   
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Nuntiya Kakanantadilok, DMD Montefiore Medical Center
  More Information

Responsible Party: Montefiore Medical Center Identifier: NCT02598778     History of Changes
Other Study ID Numbers: 2015-5583 
Study First Received: November 4, 2015
Last Updated: November 5, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Sodium Fluoride
Chlorhexidine gluconate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents processed this record on October 21, 2016