Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
744 participants
OBSERVATIONAL
2020-12-07
2024-03-31
Brief Summary
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The study will also evaluate the effectiveness of CRFP in comparison to no tooth-specific treatment control groups, including whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste; and no treatment, on caries arrest and in preventing progression to cavitation in patients with at least one early non-cavitated dental lesion.
Detailed Description
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Patients who choose CRFP will serve as the primary variable of interest. The primary objective is to assess the effectiveness of CRFP compared to other tooth specific treatments (SDF, sealants, or other FDA-approved treatments) in preventing progression to cavitation in initial dental lesions. The primary endpoint will be measured by the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.
The secondary objectives are to assess the effectiveness of CRFP compared to no tooth-specific treatment (including whole mouth treatments such as: fluoride varnish, fluoride foam, prescription toothpaste; other FDA-approved treatments; and no treatment) on 1.) caries arrest and 2.) preventing progression to cavitation in patients with at least one early dental lesion. The secondary endpoints will be measured by 1.) the percentage of patients that have caries arrest for at least one early lesion noted at baseline during the following 24 months of observation and 2.) the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Curodont Repair Fluoride Plus (Curodont) cohort
The effectiveness of Curodont treatment in this group will be compared to other treatment options and cohorts. Curodont will be professionally applied in the dental clinic. The treatment time takes about 5 minutes. Patients receive one professional dose application and be provided with homecare instructions and will be instructed to return for regular dental visits and exams according to the frequency determined by their dental team, usually every 6 months.
Curodont Repair Fluoride Plus
Self-assembling peptide that integrates calcium and phosphate ions into the same hydroxyapatite that the enamel is made of through biomimetic re-mineralization. Amino acid sequence: CH3,COQQRFEWEFEQQ,NH2.
Fluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpaste
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
Other tooth-specific initial lesion interventional treatments cohort(s)
Silver Diamine Fluoride (SDF). The treatment time is about 2 minutes.
Glass Ionomer Sealants: The treatment time takes about 5 minutes per sealant. Typically four sealants are completed in one visit.
All patients will be provided with homecare instructions and will be instructed to return for regular dental visits and exams according to the frequency determined by their dental team, usually every 6 months.
Silver Diamine Fluoride
Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. SDF works by killing pathogenic organisms and hardens softened dentin making it more acid and abrasion resistant. The ADA recommends the use of SDF in treating early lesions.
Glass Ionomer Sealant
A hydrophilic type of sealant material made with water, polymeric acid, and glass power. These sealants release fluoride over time which also helps protect against and repair initial caries lesions. The ADA recommends the use of sealants in treating occlusal early lesions.
Fluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpaste
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
Control cohort, no tooth-specific treatment or whole mouth treatment.
If a patient or their caregivers choose no tooth-specific treatment, they will be included in the control cohort. This group includes patients who chose to receive no treatment at all, as well as those who choose whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste.
Fluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpaste
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
Orthodontic cohort
Patients in active orthodontic care will be analyzed separately from other patients to account for the impact of orthodontic appliances on treatment outcomes. Orthodontic appliances are recognized by the American Dental Association Caries Risk Assessment as a risk factor for caries because they create dental plaque stagnation areas that are difficult to clean. Initial caries lesions are very frequently seen immediately surrounding orthodontic brackets (braces), yet continued plaque stagnation over the treated areas may heavily influence the success of any treatment. All groups/cohorts above will be represented in the orthodontic cohort in parallel.
Curodont Repair Fluoride Plus
Self-assembling peptide that integrates calcium and phosphate ions into the same hydroxyapatite that the enamel is made of through biomimetic re-mineralization. Amino acid sequence: CH3,COQQRFEWEFEQQ,NH2.
Silver Diamine Fluoride
Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. SDF works by killing pathogenic organisms and hardens softened dentin making it more acid and abrasion resistant. The ADA recommends the use of SDF in treating early lesions.
Glass Ionomer Sealant
A hydrophilic type of sealant material made with water, polymeric acid, and glass power. These sealants release fluoride over time which also helps protect against and repair initial caries lesions. The ADA recommends the use of sealants in treating occlusal early lesions.
Fluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpaste
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
Interventions
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Curodont Repair Fluoride Plus
Self-assembling peptide that integrates calcium and phosphate ions into the same hydroxyapatite that the enamel is made of through biomimetic re-mineralization. Amino acid sequence: CH3,COQQRFEWEFEQQ,NH2.
Silver Diamine Fluoride
Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. SDF works by killing pathogenic organisms and hardens softened dentin making it more acid and abrasion resistant. The ADA recommends the use of SDF in treating early lesions.
Glass Ionomer Sealant
A hydrophilic type of sealant material made with water, polymeric acid, and glass power. These sealants release fluoride over time which also helps protect against and repair initial caries lesions. The ADA recommends the use of sealants in treating occlusal early lesions.
Fluoride varnish
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpaste
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions
* Healthy/ ADACCS "Sound" teeth
4 Years
ALL
Yes
Sponsors
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CareQuest Institute for Oral Health
OTHER
Responsible Party
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Laura Kibbe
Laura Kibbe, BSDH, Clinical Innovation Manager
Principal Investigators
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Laura J Skaret, BS
Role: PRINCIPAL_INVESTIGATOR
CareQuest Innovation Partners
Locations
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Sarrell Dental Clinic
Dothan, Alabama, United States
DentaQuest (Advantage Dental) Oral Health Center
Westborough, Massachusetts, United States
Advantage Dental Oral Health Center
Bend, Oregon, United States
Community Dental Care
Dallas, Texas, United States
Countries
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References
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Fleming E, Afful J. Prevalence of Total and Untreated Dental Caries Among Youth: United States, 2015-2016. NCHS Data Brief. 2018 Apr;(307):1-8.
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Wright JT, Crall JJ, Fontana M, Gillette EJ, Novy BB, Dhar V, Donly K, Hewlett ER, Quinonez RB, Chaffin J, Crespin M, Iafolla T, Siegal MD, Tampi MP, Graham L, Estrich C, Carrasco-Labra A. Evidence-based clinical practice guideline for the use of pit-and-fissure sealants: A report of the American Dental Association and the American Academy of Pediatric Dentistry. J Am Dent Assoc. 2016 Aug;147(8):672-682.e12. doi: 10.1016/j.adaj.2016.06.001.
Gao SS, Zhao IS, Hiraishi N, Duangthip D, Mei ML, Lo ECM, Chu CH. Clinical Trials of Silver Diamine Fluoride in Arresting Caries among Children: A Systematic Review. JDR Clin Trans Res. 2016 Oct;1(3):201-210. doi: 10.1177/2380084416661474. Epub 2016 Aug 20.
Kind L, Stevanovic S, Wuttig S, Wimberger S, Hofer J, Muller B, Pieles U. Biomimetic Remineralization of Carious Lesions by Self-Assembling Peptide. J Dent Res. 2017 Jul;96(7):790-797. doi: 10.1177/0022034517698419. Epub 2017 Mar 27.
Saha S, Yang XB, Wijayathunga N, Harris S, Feichtinger GA, Davies RPW, Kirkham J. A biomimetic self-assembling peptide promotes bone regeneration in vivo: A rat cranial defect study. Bone. 2019 Oct;127:602-611. doi: 10.1016/j.bone.2019.06.020. Epub 2019 Jul 24.
Welk A, Ratzmann A, Reich M, Krey KF, Schwahn C. Effect of self-assembling peptide P11-4 on orthodontic treatment-induced carious lesions. Sci Rep. 2020 Apr 22;10(1):6819. doi: 10.1038/s41598-020-63633-0.
Broseler F, Tietmann C, Bommer C, Drechsel T, Heinzel-Gutenbrunner M, Jepsen S. Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries. Clin Oral Investig. 2020 Jan;24(1):123-132. doi: 10.1007/s00784-019-02901-4. Epub 2019 Apr 29.
Doberdoli D, Bommer C, Begzati A, Haliti F, Heinzel-Gutenbrunner M, Juric H. Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries. Sci Rep. 2020 Mar 6;10(1):4195. doi: 10.1038/s41598-020-60815-8.
Gozetici B, Ozturk-Bozkurt F, Toz-Akalin T. Comparative Evaluation of Resin Infiltration and Remineralisation of Noncavitated Smooth Surface Caries Lesions: 6-month Results. Oral Health Prev Dent. 2019;17(2):99-106. doi: 10.3290/j.ohpd.a42203.
Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
Brunton PA, Davies RP, Burke JL, Smith A, Aggeli A, Brookes SJ, Kirkham J. Treatment of early caries lesions using biomimetic self-assembling peptides--a clinical safety trial. Br Dent J. 2013 Aug;215(4):E6. doi: 10.1038/sj.bdj.2013.741.
Shah SV, Kibbe LJ, Heaton LJ, Desrosiers C, Wittenborn J, Filipova M, Zaydenman K, Keeper JH. Framework for fiscal impact analysis of managing initial caries lesions with noninvasive therapies. J Am Dent Assoc. 2023 Oct;154(10):897-909.e6. doi: 10.1016/j.adaj.2023.07.007.
Other Identifiers
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DQCI003
Identifier Type: -
Identifier Source: org_study_id