In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
NCT ID: NCT06010732
Last Updated: 2025-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2023-10-02
2024-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Test-Positive-Placebo
Crossover design - Cleaning, 2-3 day non-Fluoride (F) dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control) , 0 ppm F (placebo, negative control)
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Test-Placebo-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control)
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Positive-Test-Placebo
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product, 0 ppm F (placebo, negative control)
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Positive-Placebo-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 1100 ppm F as sodium fluoride (positive control), 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Placebo-Test-Positive
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control), 1100 ppm F as sodium fluoride Test Product,1100 ppm F as sodium fluoride (positive control)
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Placebo-Positive-Test
Crossover design - Cleaning, 2-3 day non-F dentifrice, Period 1 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 2 product for 2 weeks, 4-5 day washout, cleaning, 2-3 day non-F dentifrice, Period 3 product for 2 weeks. Product sequence: 0 ppm F (placebo, negative control),1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Interventions
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0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
Yes
Sponsors
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HALEON
INDUSTRY
Indiana University
OTHER
Responsible Party
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Domenick Zero
Principal Investigator
Principal Investigators
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Domenick Zero, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Anderson Hara, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Frank Lippert, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
Indianapolis, Indiana, United States
Countries
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References
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Clinical Aspects of De/Remineralization of Teeth. Proceedings of Models Conference 1994. Rochester, New York, June 11-14, 1994. Adv Dent Res. 1995 Nov;9(3):169-340. No abstract available.
Corpron RE, Clark JW, Tsai A, More FG, Merrill DF, Kowalski CJ, Tice TR, Rowe CE. Intraoral effects of a fluoride-releasing device on acid-softened enamel. J Am Dent Assoc. 1986 Sep;113(3):383-8. doi: 10.14219/jada.archive.1986.0202.
Featherstone JD, Mellberg JR. Relative rates of progress of artificial carious lesions in bovine, ovine and human enamel. Caries Res. 1981;15(1):109-14. doi: 10.1159/000260508. No abstract available.
Cate JM, Arends J. Remineralization of artificial enamel lesions in vitro. Caries Res. 1977;11(5):277-86. doi: 10.1159/000260279. No abstract available.
Koulourides T, Phantumvanit P, Munksgaard EC, Housch T. An intraoral model used for studies of fluoride incorporation in enamel. J Oral Pathol. 1974;3(4):185-96. doi: 10.1111/j.1600-0714.1974.tb01710.x. No abstract available.
Lippert F, Butler A, Lynch RJ. Characteristics of methylcellulose acid gel lesions created in human and bovine enamel. Caries Res. 2013;47(1):50-5. doi: 10.1159/000343164. Epub 2012 Oct 25.
Lippert F, Hara AT. Fluoride dose-response of human and bovine enamel caries lesions under remineralizing conditions. Am J Dent. 2012 Aug;25(4):205-9.
Lippert F, Lynch RJ. Comparison of Knoop and Vickers surface microhardness and transverse microradiography for the study of early caries lesion formation in human and bovine enamel. Arch Oral Biol. 2014 Jul;59(7):704-10. doi: 10.1016/j.archoralbio.2014.04.005. Epub 2014 Apr 21.
Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2003;2003(1):CD002278. doi: 10.1002/14651858.CD002278.
Mellberg JR. Hard-tissue substrates for evaluation of cariogenic and anti-cariogenic activity in situ. J Dent Res. 1992 Apr;71 Spec No:913-9. doi: 10.1177/002203459207100S25.
Proskin HM, Chilton NW, Kingman A. Interim report of the ad hoc committee for the consideration of statistical concerns related to the use of intra-oral models in submissions for product claims approval to the American Dental Association. J Dent Res. 1992 Apr;71 Spec No:949-52. doi: 10.1177/002203459207100S31.
Sakkab NY, Cilley WA, Haberman JP. Fluoride in deciduous teeth from an anti-caries clinical study. J Dent Res. 1984 Oct;63(10):1201-5. doi: 10.1177/00220345840630100601.
Twetman S, Axelsson S, Dahlgren H, Holm AK, Kallestal C, Lagerlof F, Lingstrom P, Mejare I, Nordenram G, Norlund A, Petersson LG, Soder B. Caries-preventive effect of fluoride toothpaste: a systematic review. Acta Odontol Scand. 2003 Dec;61(6):347-55. doi: 10.1080/00016350310007590.
Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.
White DJ. Use of synthetic polymer gels for artificial carious lesion preparation. Caries Res. 1987;21(3):228-42. doi: 10.1159/000261026. No abstract available.
Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.
Zero DT, Rahbek I, Fu J, Proskin HM, Featherstone JD. Comparison of the iodide permeability test, the surface microhardness test, and mineral dissolution of bovine enamel following acid challenge. Caries Res. 1990;24(3):181-8. doi: 10.1159/000261263.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23-I-121
Identifier Type: -
Identifier Source: org_study_id
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