Clinical trial NCT06010732: In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
Official title: Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Caries
Keywords: Caries
Remineralization
Fluoride
Dentifrice
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: HALEON
First posted: 2023-08-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.

Detailed description: This will be a double blind, single center, 3-way crossover design study. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessible plaque and calculus and will be provided with a non-fluoride dentifrice to use until their next visit. At the beginning of each testing period, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth (the specimen site may extend into the buccal flange area, if needed) of the same side of the partial denture. Once specimens are placed, subjects will wear their partial dentures twenty-four hours a day and use their assigned toothpaste twice daily, as instructed, until their next visit. Specimens will be removed after two weeks, and the subjects will undergo at least a four- to five-day washout period followed by another cleaning and two to three day lead in period. This process will be repeated until all subjects have used all three test products. Changes in the mineral content of the enamel specimens will be assessed using surface microhardness (SMH) and transverse microradiography (TMR). Enamel fluoride uptake (EFU) will be determined using the microdrill enamel biopsy technique. In addition, the net acid resistance (NAR) and the comparative acid resistance (CAR) of the demineralized enamel specimens will be determined.

Eligibility criteria: Inclusion Criteria:

1. provide voluntary, written informed consent;
2. be between 18 and 85 years old;
3. understand and be willing, able and likely to comply with all study procedures and restrictions;
4. be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth on the same side;
5. be willing and capable of wearing their removable partial denture 24 hours a day for three (3), two-week treatment periods;
6. be willing to allow study personnel to drill specimen sites in two denture teeth in the posterior section of one side of their lower partial denture, which may extend into the buccal flange area below the teeth;
7. be in good medical and dental health with no active caries or periodontal disease; NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1; and
8. 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).

Exclusion Criteria:

1. currently be pregnant, intending to become pregnant during the study period or breast feeding;
2. currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
3. currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
4. known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients;
5. have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
6. be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.

Primary outcomes:
measure: Percent Surface Microhardness Recovery (%SMH Recovery)
timeFrame: at the end of each two-week treatment per
Secondary outcomes:
measure: Enamel Fluoride Uptake (µg F/cm2)
timeFrame: at the end of each two-week treatment period
measure: Percent Net Acid Resistance
timeFrame: at the end of each two-week treatment period
measure: Percentage Comparative Acid Resistance
timeFrame: at the end of each two-week treatment period
measure: Integrated Mineral Loss (∆Z)
timeFrame: at the end of each two-week treatment period
measure: Lesion Depth (µm)
timeFrame: at the end of each two-week treatment period
measure: Maximum Mineral Density at the Surface-zone (SZmax)
timeFrame: at the end of each two-week treatment period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
state: Indiana
Study officials:
affiliation: Indiana University
name: Domenick Zero, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Anderson Hara, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Frank Lippert, PhD
role: PRINCIPAL_INVESTIGATOR
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