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| Name | Class |
|---|---|
| HALEON | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test-Positive-Placebo | Other | 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) |
|
| Test-Placebo-Positive | Other | 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) |
|
| Positive-Test-Placebo | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0 ppm F (placebo, negative control) | Drug | • Each subject will use this product during one of the three treatment periods in the crossover study design. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Surface Microhardness Recovery (%SMH Recovery) | The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure. | at the end of each two-week treatment per |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel Fluoride Uptake (µg F/cm2) | The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of ~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenick Zero, DDS, MS | Indiana University | Principal Investigator |
| Anderson Hara, DDS, PhD | Indiana University | Principal Investigator |
| Frank Lippert, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8615941 | Background | 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. | |
| 3463611 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Crossover Period 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2023 |
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double blind
| Positive-Placebo-Test | Other | 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 |
|
| Placebo-Test-Positive | Other | 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) |
|
| Placebo-Positive-Test | Other | 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 |
|
|
| 1100 ppm F as sodium fluoride (positive control) | Drug | • 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 | Drug | • Each subject will use this product during one of the three treatment periods in the crossover study design. |
|
|
| at the end of each two-week treatment period |
| Percent Net Acid Resistance | % Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization | at the end of each two-week treatment period |
| Percentage Comparative Acid Resistance | % Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization | at the end of each two-week treatment period |
| Integrated Mineral Loss (∆Z) | ∆Z= [(lesion depth x 87) - area under the curve*] calculated using Transverse Microradiography software program | at the end of each two-week treatment period |
| Lesion Depth (µm) | Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program | at the end of each two-week treatment period |
| Maximum Mineral Density at the Surface-zone (SZmax) | SZmax was determined using Transverse Microradiography software program | at the end of each two-week treatment period |
| 6937246 | Background | 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. |
| 18285 | Background | 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. |
| 4219029 | Background | 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. |
| 23108261 | Background | 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. |
| 23082383 | Background | 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. |
| 24798979 | Background | 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. |
| 12535435 | Background | 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. |
| 1592986 | Background | 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. |
| 1592992 | Background | 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. |
| 6592201 | Background | 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. |
| 14960006 | Background | 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. |
| 20091655 | Background | 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. |
| 3471346 | Background | 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. |
| 8615944 | Background | Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501. |
| 2364403 | Background | 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. |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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 |
| FG004 | 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) |
| FG005 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Between Periods 1 and 2 |
|
|
| Crossover Period 2 |
|
|
| Washout Between Periods 2 and 3 |
|
| Crossover Period 3 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This was a three-way crossover design: 0 ppm F (placebo, negative control;1100 ppm F as sodium fluoride (positive control); 1100 ppm F as sodium fluoride Test Product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Surface Microhardness Recovery (%SMH Recovery) | The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure. | Analyses were performed using all available data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Surface Microhardness Recovery | at the end of each two-week treatment per |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Enamel Fluoride Uptake (µg F/cm2) | The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of ~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2 | Analyses were performed using all available data. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | µg F/cm2 | at the end of each two-week treatment period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Net Acid Resistance | % Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization | Analyses were performed using all available data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Net Acid Resistance | at the end of each two-week treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Comparative Acid Resistance | % Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization | Analyses were performed using all available data. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Percentage Comparative Acid Resistance | at the end of each two-week treatment period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Mineral Loss (∆Z) | ∆Z= [(lesion depth x 87) - area under the curve*] calculated using Transverse Microradiography software program | Analyses were performed using all available data. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Integrated Mineral Loss (∆Z) | at the end of each two-week treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lesion Depth (µm) | Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program | Analyses were performed using all available data. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | µm | at the end of each two-week treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Mineral Density at the Surface-zone (SZmax) | SZmax was determined using Transverse Microradiography software program | Analyses were performed using all available data. | Posted | Least Squares Mean | 95% Confidence Interval | Maximum mineral density at the surface-z | at the end of each two-week treatment period |
|
|
5 months
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0 Ppm F (Placebo) | Each subject used this product during one of the three treatment periods in the crossover study design. | 0 | 52 | 1 | 52 | 23 | 52 |
| EG001 | 1100 Ppm F as Sodium Fluoride (Positive Control) | Each subject used this product during one of the three treatment periods in the crossover study design. | 0 | 52 | 0 | 52 | 16 | 52 |
| EG002 | 1100 Ppm F as Sodium Fluoride Test Product | Each subject used this product during one of the three treatment periods in the crossover study design. | 0 | 52 | 1 | 52 | 19 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel Obstructiion | Gastrointestinal disorders | Table | Systematic Assessment | Bowel obstruction due to adhesions. The subject had abdominal distress with nausea and vomiting which required hospital admission and surgery from which the subject fully recovered. |
|
| Migraine vestibulaire | Nervous system disorders | Table | Systematic Assessment | Subject had a history of migraines and experienced severe migraine that required hospitalization. The subject received treatment with Meclizine and all symptoms resolved in a few days. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | Table | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | Table | Systematic Assessment |
| |
| Cold Sweats | Nervous system disorders | Table | Systematic Assessment |
| |
| Lack of balance | Nervous system disorders | Table | Systematic Assessment |
| |
| Common cold | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Erythema Mandibular Ridge | Gastrointestinal disorders | Table | Systematic Assessment | Erythema due to partial denture friction |
|
| Abdominal Pain | Gastrointestinal disorders | Table | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | Table | Systematic Assessment |
| |
| Dehydration | General disorders | Table | Systematic Assessment |
| |
| Prolonged Post Operative Lleus | Gastrointestinal disorders | Table | Systematic Assessment |
| |
| Dry, cracked lower lip | Skin and subcutaneous tissue disorders | Table | Systematic Assessment |
| |
| Burning Sensation Oral Cavity | Gastrointestinal disorders | Table | Systematic Assessment |
| |
| Transient Sour Sensation in Oral Cavity | Gastrointestinal disorders | Table | Systematic Assessment | Transient Sour Sensation in Mandibular Posterior Area, while eating. bilateral |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Sciatica Nerve Pain | Nervous system disorders | Table | Systematic Assessment | Sciatica, left side pain |
|
| Kidney Infection | Infections and infestations | Table | Systematic Assessment |
| |
| Fractured Metal Frame of the Mandibular Partial | Product Issues | Table | Systematic Assessment | The metal framework of the subjects partial denture appliance broke. |
|
| Earache | Ear and labyrinth disorders | Table | Systematic Assessment |
| |
| Oral ulcer | Gastrointestinal disorders | Table | Systematic Assessment | Oral ulcer due to partial denture friction |
|
| Herpetic Lesion Upper Lip | Skin and subcutaneous tissue disorders | Table | Systematic Assessment |
| |
| Sore throat | Infections and infestations | Table | Systematic Assessment |
| |
| Dry and Chapped Lower Lip | Skin and subcutaneous tissue disorders | Table | Systematic Assessment |
| |
| Swollen Lower Lip | Skin and subcutaneous tissue disorders | Table | Systematic Assessment |
| |
| Tenderness Oral Cavity | Gastrointestinal disorders | Table | Systematic Assessment | Tenderness Mandibular Left Side Edentulous pre-molar area from Partial Denture Friction |
|
| Sinus Headache | Nervous system disorders | Table | Systematic Assessment |
| |
| Basel cell carcinoma | Skin and subcutaneous tissue disorders | Table | Systematic Assessment | Basel cell carcinoma on the skin of left thigh treated with surgical excision |
|
| Bladder Infection | Infections and infestations | Table | Systematic Assessment |
| |
| Worsening of the lower back pain | Musculoskeletal and connective tissue disorders | Table | Systematic Assessment |
| |
| Erythema, Hard palate | Gastrointestinal disorders | Table | Systematic Assessment | Erythema, Hard palate 3X8mm due to food burn |
|
| Pain anterior gingiva | Gastrointestinal disorders | Table | Systematic Assessment | Pain from wearing partial at night with C-PAP mask on anterior gingiva |
|
| Erythema buccal mucosa due to cheek bite | Gastrointestinal disorders | Table | Systematic Assessment | Erythema on left side of buccal mucosa posterior 3mmX3mm due to cheek bite |
|
| Body ache from shingle vaccine | General disorders | Table | Systematic Assessment |
| |
| Worsening of COPD symptoms | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Worsening of Asthma symptoms | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Muscle Strain | Musculoskeletal and connective tissue disorders | Table | Systematic Assessment | Muscle Strain - Left shoulder blade |
|
| Worsening of Chest Pain | General disorders | Table | Systematic Assessment |
| |
| Stuffy nose | Respiratory, thoracic and mediastinal disorders | Table | Systematic Assessment |
| |
| Headache | Nervous system disorders | Table | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Domenick T. Zero | Indiana University School of Dentistry | 3179877507 | dzero@iu.edu |
| Feb 19, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| broken denture |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Difference calculated as Test-Positive Control
| Superiority |
| Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level. | Mixed Models Analysis | Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product. | <0.001 | No alpha-level adjustments for multiple comparisons adjustments were applied. | Mean Difference (Final Values) | 27.2 | 2-Sided | 95 | 21.7 | 32.6 | Difference calculated as Test-Placebo | Superiority |
| Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level. | Mixed Models Analysis | Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product. | <0.001 | No alpha-level adjustments for multiple comparisons adjustments were applied. | Mean Difference (Final Values) | 27.2 | 2-Sided | 95 | 21.7 | 32.7 | Difference calculated as Positive Control-Placebo | Superiority |
Each subject used this product during one of the three treatment periods in the crossover study design.
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