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Microbial Testing for Caries Risk Assessment and Use of Adjunctive Therapies

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ClinicalTrials.gov Identifier: NCT03389373
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Specific Aims

  1. Assess CG (Cariogenic) Saliva-Check Mutans® saliva testing for identification of high caries risk patients
  2. Explore the topical effects of PreviDent® 5000 Plus toothpaste (FDA approved drug) on MS counts and plaque scores in high risk children after 4-6 week.
  3. Examine the effects of frequent hygiene reminders (two phone call follow-ups) on caries causing bacterial counts and plaque scores in high risk children after 4-6 weeks.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Prevident 5000 Plus Behavioral: Oral hygiene (OHI) reminder Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Groups that will be randomly assigned to one of four treatment groups:

  1. Over-the-counter toothpaste without frequent hygiene reminders
  2. Over-the-counter toothpaste with frequent hygiene reminders
  3. Prescription fluoride toothpaste (FDA approved) without frequent hygiene reminders
  4. Prescription fluoride toothpaste (FDA approved) with frequent hygiene reminders
Masking: Single (Care Provider)
Masking Description: This study will have 4 different groups of research subjects like you. To decide which group you will be in, we will use a method of chance. This method is like flipping a coin or rolling dice. Each group will get slightly different care. The care provider will be blinded to group assignment as hygiene bags with different types of toothpaste will be provided to parent. Parent will have specific instructions related to either the over-the-counter toothpaste or the prescription toothpaste within the hygiene bag.
Primary Purpose: Prevention
Official Title: Microbial Testing for Caries Risk Assessment and Use of Adjunctive Therapies
Estimated Study Start Date : January 16, 2018
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Listerine
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: OTC toothpaste

The group will be provided with a hygiene bag containing over the counter toothpaste and in-office hygiene instructions.

No intervention.

Active Comparator: OTC toothpaste with OHI call

The group will be provided with a hygiene bag containing over the counter toothpaste, in-office hygiene instructions, and follow-up at-home hygiene reminders.

Intervention: 2 Oral hygiene (OHI) reminder phone calls

Behavioral: Oral hygiene (OHI) reminder
Groups assigned to frequent oral hygiene reminders will receive 2 Oral hygiene (OHI) reminder phone calls between their initial and follow-up visits to check-in with parents and remind them of appropriate at home oral hygiene measures
Other Name: Phone calls
Experimental: Prescription toothpaste
The group will be provided with a hygiene bag containing Prevident5000 Plus toothpaste and in-office hygiene instructions Intervention: Prevident5000 high fluoride toothpaste
Drug: Prevident 5000 Plus
Prescription toothpaste with 5 times the level of toothpaste compared to over the counter (OTC) toothpaste.
Other Name: Prescription Fluoride Toothpaste
Experimental: Prescription toothpaste with OHI call

The group will be provided with a hygiene bag containing Prevident5000toothpaste, in-office hygiene instructions, and follow-up at-home hygiene reminders.

Intervention: Prevident5000 high fluoride toothpaste with 2 Oral hygiene (OHI) reminder phone calls

Drug: Prevident 5000 Plus
Prescription toothpaste with 5 times the level of toothpaste compared to over the counter (OTC) toothpaste.
Other Name: Prescription Fluoride Toothpaste
Behavioral: Oral hygiene (OHI) reminder
Groups assigned to frequent oral hygiene reminders will receive 2 Oral hygiene (OHI) reminder phone calls between their initial and follow-up visits to check-in with parents and remind them of appropriate at home oral hygiene measures
Other Name: Phone calls



Primary Outcome Measures :
  1. Count of Strep Mutans bacterial [ Time Frame: 4 weeks ]
    Bacterial (MS) samples resulting in〖5x10〗^5 colony-forming units per milliliter of saliva (CFU/mL) indicates a low caries risk. In contrast, >〖5x10〗^5 CFU/mL of MS in a saliva sample correlates to a moderate or high caries risk. This study is designed to use saliva sampling to determine a non-surgical adjunctive therapy to help lower cavity causing bacteria.


Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: 4 weeks ]
    An index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin. A score of 0 to 3 (0=no plaque, 1=minimal plaque, 2 = moderate plaque, 3= extensive plaque is assigned to each of 5 division on the tooth). The score is then divided by 5. The patient's resultant plaque rating is considered excellent if the score is 0, Good if it is between 0.1-1.7, Fair if it is between 1.8-3.4 and Poor if it is between 3.5-5. The hope is to see a reduction of plaque score in study participants at the follow-up visit 4 weeks later.



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Ages Eligible for Study:   24 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be a patient of record at Children's Hospital Colorado Dental Center
  • Child must fall between 24 and 96 months of age
  • Caregiver must speak and read English or Spanish and be the child's legal guardian
  • Child must present with full primary dentition
  • Child must be diagnosed with having a high caries risk based on the caries-risk assessment set forth by the American Academy of Pediatric Dentistry (AAPD)
  • Child must be diagnosed with having 4 or more teeth with caries into dentin, no previous dental restorations, and has a medical history classified as ASA I or ASA II
  • Caregivers must have access to one phone line

Exclusion Criteria:

  • Patients with a complex medical history classified as being greater than ASA II
  • Patients with recent dose of antibiotics within the previous two weeks or who present with a low caries risk set forth by the AAPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389373


Contacts
Contact: Camille V Gannam, DMD MS 530-414-1966 Camille.Gannam@childrenscolorado.org
Contact: Kellie McGinley, DDS 775-815-8528 Kellie.McGinley@childrenscolorado.org

Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Camille V Gannam, DMD MS University of Colorado, Denver

Additional Information:
Publications of Results:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03389373     History of Changes
Other Study ID Numbers: 17-1535
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a small resident research project comparing the effect of Prevident5000 plus versus over the counter toothpaste on cariogenic bacteria counts as well as the effect of frequent hygiene reminders on oral hygiene (plaque score).

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Colorado, Denver:
Dental Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents