Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction

NCT02598778 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2015-5583
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin wax chewing gum replaced the originally planned coconut oil and served as a placebo comparator.

Conditions

Dental Caries

Keywords

Streptococcus Mutans; Saliva

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)

  Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels. Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change).

  Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)

Study Arms (4)

Chlorhexidine gluconate (0.12%)

ACTIVE COMPARATOR

An oral rinse given to pediatric patients in routine practice within the standard of care.

Drug: Chlorhexidine gluconate (0.12%)

Sodium Fluoride (0.05%)

ACTIVE COMPARATOR

An oral rinse given to pediatric patients in routine practice within the standard of care.

Drug: Sodium Fluoride (0.05%)

Paraffin wax chewing gum (sugar-free)

PLACEBO COMPARATOR

A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained.

Other: Paraffin wax chewing gum (sugar-free)

Deionized water

PLACEBO COMPARATOR

Water that has had the majority of its ions removed.

Other: Deionized water

Interventions

Chlorhexidine gluconate (0.12%) DRUG

30 second oral rinse of 10mL of solution

Also known as: Peridex

Chlorhexidine gluconate (0.12%)

Sodium Fluoride (0.05%) DRUG

30 second oral rinse of 10mL of solution

Also known as: ACT brand anticavity mouthrinse

Sodium Fluoride (0.05%)

Paraffin wax chewing gum (sugar-free) OTHER

Approximately two minutes of chew time

Paraffin wax chewing gum (sugar-free)

Deionized water OTHER

30 second oral rinse of 10mL of solution

Deionized water

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients presenting to the dental clinic for routine dental treatment (including recall exams, new patient exams, and operative appointments) who are American Society of Anesthesia (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
• Had untreated cavities
• Nothing to eat/drink for 1 hour prior to dental appointment

You may not qualify if:

• Patients who are ASA class III, IV, V or VI
• 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/participant
• Patient presenting to the clinic as a walk in or emergency appointment
• Patient experiencing any pain or sensitivity
• Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to the Frankl Behavioral Rating Scale

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

chlorhexidine gluconate; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Kakanantadilok, Nuntiya
• Organization: MMC - Dentistry

nkakanan@montefiore.org

(888) 700-6623

Study Officials

• Nuntiya Kakanantadilok, DMD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dentistry

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-10

Locations

US (1)