An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy

NCT01665911 | Completed Results

• 1 other identifier: 12-I-086
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.

Conditions

Caries

Keywords

Caries

Outcome Measures

Primary Outcomes (1)

• % Surface Microhardness (SMH) Recovery Score Per Each of Five Arms

  * surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation: * SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).

  Three Weeks per each of five arms

Secondary Outcomes (2)

• % Acid Resistance Score Per Each of Five Arms

  Three Weeks per each of five arms

• Enamel Fluoride Uptake Per Each of Five Arms

  Three Weeks per each of five arms

Study Arms (5)

Arm 1

OTHER

non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk

Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml

Arm 2

OTHER

non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk

Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml

Arm 3

OTHER

non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk

Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml

Arm 4

OTHER

non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk

Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml

Arm 5

ACTIVE COMPARATOR

non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk

Drug: 1.5 mg Sodium Fluoride in 100 ml milk; Drug: 1.5 mg sodium fluoride in 200 ml milk; Drug: 3 mg sodium fluoride in 100 ml milk; Drug: 3 mg sodium fluoride in 200 ml milk; Other: Non-fluoridated milk, 200 ml

Interventions

1.5 mg Sodium Fluoride in 100 ml milk DRUG

Each subject will use this product during one of the five treatment periods in the crossover study design.

Also known as: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

1.5 mg sodium fluoride in 200 ml milk DRUG

Each subject will use this product during one of the five treatment periods in the crossover study design.

Also known as: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

3 mg sodium fluoride in 100 ml milk DRUG

Each subject will use this product during one of the five treatment periods in the crossover study design.

Also known as: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

3 mg sodium fluoride in 200 ml milk DRUG

Each subject will use this product during one of the five treatment periods in the crossover study design

Also known as: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00), Kroger Nonfat Dry Milk reconstituted with fluoride-free milk

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

Non-fluoridated milk, 200 ml OTHER

Each subject will use this product during one of the five treatment periods in the crossover study design.

Also known as: Kroger Nonfat Dry Milk

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
• be between 18 and 80 years old and in general good health;
• willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
• wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
• be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
• be in good dental health with no active caries or periodontal disease;
• agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
• have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).
• Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening

You may not qualify if:

• be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.
• have any medical condition that could be expected to interfere with the subject's safety during the study period;
• demonstrate an inability to comply with study procedures;
• have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning\* or previous use of the weight loss medications Fen Phen® or Redux®. (\*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
• be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
• be lactose intolerant or have known allergy or intolerance to milk or milk products

Sponsors & Collaborators

• Frank Lippert: lead
• The Borrow Foundation: collaborator

Study Sites (1)

Oral Health Research Institute, Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Lippert F, Martinez-Mier EA, Zero DT. An in situ caries study on the interplay between fluoride dose and concentration in milk. J Dent. 2014 Jul;42(7):883-90. doi: 10.1016/j.jdent.2014.01.010. Epub 2014 Feb 7.

  PMID: 24513113 RESULT

MeSH Terms

Interventions

Sodium Fluoride; Milk

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Results Point of Contact

• Title: Frank Lippert
• Organization: Indiana University School of Dentistry

flippert@iu.edu

317-274-8822

Study Officials

• Frank Lippert, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Domenick Zero, DDS, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 16, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 23, 2015
• Results First Posted: August 21, 2014

Record last verified: 2015-02

Locations

US (1)