Initial CariesELMONCT04933331
Early Caries Lesion Management Observational Study
An observational study of Initial Caries and Arrested Dental Caries, run by CareQuest Institute for Oral Health at 4 sites in United States.
Trial summary
The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Initial Caries, Arrested Dental Caries, Cavitated Caries
- What is being tested?
- Curodont Repair Fluoride Plus, Silver Diamine Fluoride and Glass Ionomer Sealant
- Type of treatment
- Medical device
- How many people
- 744 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Dec 2020to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This project will include patients of specified DentaQuest CareGroup clinics in Massachusetts, Alabama, Texas, and Oregon. There will be no special inclusion/exclusion criteria by race and/or ethnic origin. * The pediatric cohort will include patients with permanent teeth up to the 21st birthday. * The orthodontic cohort will include all ages. * The adult cohort will include all patients age 21 and above.
Who may be able to join
- All patients with permanent teeth who are diagnosed with at least one American Dental Association Caries Classification System (ADACCS) "Initial" caries lesion in a permanent tooth, will be included in this analysis.
Who cannot join
- Primary teeth
- Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions
- Healthy/ ADACCS "Sound" teeth
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advantage Dental Oral Health Center
Bend, Oregon, 97701
Community Dental Care
Dallas, Texas, 75246
Sarrell Dental Clinic
Dothan, Alabama, 36303
DentaQuest (Advantage Dental) Oral Health Center
Westborough, Massachusetts, 01581
About this study
Official title: An Observational Multi-cite Study to Evaluate and Compare the Effectiveness of Various Tooth Specific Treatments in the Management of Early Caries Lesions
The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion.
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.
Read the detailed description
Study subjects will be enrolled upon diagnosis of at least one ADA Caries Classification system "initial" caries lesion. Subjects will be further sorted into study cohorts based on the non-invasive treatment option they select. The early lesions will be followed for 24 months after the date of the initial caries lesion diagnosis or the date of the first non-invasive treatment applied to the lesion.
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
- Initial Caries, Arrested Dental Caries, Cavitated Caries, Dental Caries, Dental Caries in Children
- Being tested
- Curodont Repair Fluoride Plus, Silver Diamine Fluoride, Glass Ionomer Sealant, Fluoride varnish, Fluoride toothpaste
- Keywords
- Curodont Repair Fluoride Plus, silver diamine fluoride, glass ionomer sealants, Fluoride Varnish, minimally invasive dentistry, non-invasive dentistry, Initial Caries, Arrested Dental Caries, dental caries, Cavitated Caries, Restorative Dental Treatment, Dental restorations
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont Repair Fluoride PlusDrug
Also called Curolox, p11-4
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 FluorideDevice
Also called SDF, Silver Nitrate
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 SealantDevice
Also called GI 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 varnishDevice
2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
Fluoride toothpasteDrug
Also called Prevident, Clinpro
Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Curodont Repair Fluoride Plus; Device: Fluoride varnish; Drug: Fluoride toothpaste | |
| 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. Receives: Device: Silver Diamine Fluoride; Device: Glass Ionomer Sealant; Device: Fluoride varnish; Drug: Fluoride toothpaste | |
| 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. Receives: Device: Fluoride varnish; Drug: Fluoride toothpaste | |
| 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. Receives: Drug: Curodont Repair Fluoride Plus; Device: Silver Diamine Fluoride; Device: Glass Ionomer Sealant; Device: Fluoride varnish; Drug: Fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation.
The percentage of patients treated with CRFP that require operative treatment for at least one early lesion within the 24 months.
Measured: 24 months
Secondary outcomes (2)
To assess the effectiveness of CRFP compared to no tooth specific treatments (including whole mouth treatments) on caries arrest.
The percentage of patients that have caries arrest for at least one early lesion noted at baseline during the 24 months of observation from baseline.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of CRFP compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.
The percentage of patients that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start7 Dec 2020
- Primary completion15 Nov 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Initial CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareQuest Institute for Oral Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Kibbe, CareQuest Institute for Oral Health
- Investigators
- Laura J Skaret, BS, Principal investigator, CareQuest Innovation Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933331
- Sponsor's protocol ID
- DQCI003
- Acronym
- ELMO
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2021
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study data will be deidentified and stored on a secure server. There will be no plans to release individual participant data.
Publications
Brantley CF, Bader JD, Shugars DA, Nesbit SP. Does the cycle of rerestoration lead to larger restorations? J Am Dent Assoc. 1995 Oct;126(10):1407-13. doi: 10.14219/jada.archive.1995.0052.
PubMed 7594013Fleming E, Afful J. Prevalence of Total and Untreated Dental Caries Among Youth: United States, 2015-2016. NCHS Data Brief. 2018 Apr;(307):1-8.
PubMed 29717975Seirawan H, Faust S, Mulligan R. The impact of oral health on the academic performance of disadvantaged children. Am J Public Health. 2012 Sep;102(9):1729-34. doi: 10.2105/AJPH.2011.300478. Epub 2012 Jul 19.
PubMed 22813093Jackson SL, Vann WF Jr, Kotch JB, Pahel BT, Lee JY. Impact of poor oral health on children's school attendance and performance. Am J Public Health. 2011 Oct;101(10):1900-6. doi: 10.2105/AJPH.2010.200915. Epub 2011 Feb 17.
PubMed 21330579Slayton RL, Urquhart O, Araujo MWB, Fontana M, Guzman-Armstrong S, Nascimento MM, Novy BB, Tinanoff N, Weyant RJ, Wolff MS, Young DA, Zero DT, Tampi MP, Pilcher L, Banfield L, Carrasco-Labra A. Evidence-based clinical practice guideline on nonrestorative treatments for carious lesions: A report from the American Dental Association. J Am Dent Assoc. 2018 Oct;149(10):837-849.e19. doi: 10.1016/j.adaj.2018.07.002.
PubMed 30261951Wright 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.
PubMed 27470525Gao 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.
PubMed 30931743Kind 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.
PubMed 28346861Saha 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.
PubMed 31351196Welk 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.
PubMed 32321955Broseler 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.
PubMed 31037343Doberdoli 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.
PubMed 32144336Gozetici 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.
PubMed 30874252Alkilzy 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.
PubMed 28892645Brunton 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.
PubMed 23969679
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multi-cite Study to Evaluate and Compare the Effectiveness of Various Tooth Specific Treatments in the Management of Early Caries Lesions
- ClinicalTrials.gov ID
- NCT04933331
- Acronym / sponsor ID
- ELMO / DQCI003
- Conditions
- Initial Caries, Arrested Dental Caries, Cavitated Caries, Dental Caries, Dental Caries in Children
- Keywords
- Curodont Repair Fluoride Plus, silver diamine fluoride, glass ionomer sealants, Fluoride Varnish, minimally invasive dentistry, non-invasive dentistry, Initial Caries, Arrested Dental Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 744 participants (estimated)
- Lead sponsor
- CareQuest Institute for Oral HealthUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion.
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
Study subjects will be enrolled upon diagnosis of at least one ADA Caries Classification system "initial" caries lesion. Subjects will be further sorted into study cohorts based on the non-invasive treatment option they select. The early lesions will be followed for 24 months after the date of the initial caries lesion diagnosis or the date of the first non-invasive treatment applied to the lesion.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Curodont Repair Fluoride Plus (Curodont) cohort | – | Drug: Curodont Repair Fluoride Plus, Device: Fluoride varnish, Drug: Fluoride toothpasteThe 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. |
| Other tooth-specific initial lesion interventional treatments cohort(s) | – | Device: Silver Diamine Fluoride, Device: Glass Ionomer Sealant, Device: Fluoride varnish, Drug: Fluoride toothpasteSilver 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. |
| Control cohort, no tooth-specific treatment or whole mouth treatment. | – | Device: Fluoride varnish, Drug: Fluoride toothpasteIf 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. |
| Orthodontic cohort | – | Drug: Curodont Repair Fluoride Plus, Device: Silver Diamine Fluoride, Device: Glass Ionomer Sealant, Device: Fluoride varnish, Drug: Fluoride toothpastePatients 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This project will include patients of specified DentaQuest CareGroup clinics in Massachusetts, Alabama, Texas, and Oregon. There will be no special inclusion/exclusion criteria by race and/or ethnic origin. * The pediatric cohort will include patients with permanent teeth up to the 21st birthday. * The orthodontic cohort will include all ages. * The adult cohort will include all patients age 21 and above.
Key inclusion criteria (1 listed)
- All patients with permanent teeth who are diagnosed with at least one American Dental Association Caries Classification System (ADACCS) "Initial" caries lesion in a permanent tooth, will be included in this analysis.
Key exclusion criteria (3 listed)
- Primary teeth
- Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions
- Healthy/ ADACCS "Sound" teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curodont Repair Fluoride PlusAlso: Curolox, p11-4Self-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. | Drug | Curodont Repair Fluoride Plus (Curodont) cohort, Orthodontic cohort |
| Silver Diamine FluorideAlso: SDF, Silver NitrateSilver 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. | Device | Orthodontic cohort, Other tooth-specific initial lesion interventional treatments cohort(s) |
| Glass Ionomer SealantAlso: GI SealantA 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. | Device | Orthodontic cohort, Other tooth-specific initial lesion interventional treatments cohort(s) |
| Fluoride varnish2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules. | Device | Control cohort, no tooth-specific treatment or whole mouth treatment., Curodont Repair Fluoride Plus (Curodont) cohort, Orthodontic cohort, Other tooth-specific initial lesion interventional treatments cohort(s) |
| Fluoride toothpasteAlso: Prevident, ClinproPrescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries. | Drug | Control cohort, no tooth-specific treatment or whole mouth treatment., Curodont Repair Fluoride Plus (Curodont) cohort, Orthodontic cohort, Other tooth-specific initial lesion interventional treatments cohort(s) |
Primary outcome
To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation.
Time frame: 24 months
The percentage of patients treated with CRFP that require operative treatment for at least one early lesion within the 24 months.
2 secondary outcomes
To assess the effectiveness of CRFP compared to no tooth specific treatments (including whole mouth treatments) on caries arrest.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
To assess the effectiveness of CRFP compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 7594013Brantley CF, Bader JD, Shugars DA, Nesbit SP. Does the cycle of rerestoration lead to larger restorations? J Am Dent Assoc. 1995 Oct;126(10):1407-13. doi: 10.14219/jada.archive.1995.0052.
- Background: PubMed 29717975Fleming E, Afful J. Prevalence of Total and Untreated Dental Caries Among Youth: United States, 2015-2016. NCHS Data Brief. 2018 Apr;(307):1-8.
- Background: PubMed 22813093Seirawan H, Faust S, Mulligan R. The impact of oral health on the academic performance of disadvantaged children. Am J Public Health. 2012 Sep;102(9):1729-34. doi: 10.2105/AJPH.2011.300478. Epub 2012 Jul 19.
- Background: PubMed 21330579Jackson SL, Vann WF Jr, Kotch JB, Pahel BT, Lee JY. Impact of poor oral health on children's school attendance and performance. Am J Public Health. 2011 Oct;101(10):1900-6. doi: 10.2105/AJPH.2010.200915. Epub 2011 Feb 17.
- Background: PubMed 30261951Slayton RL, Urquhart O, Araujo MWB, Fontana M, Guzman-Armstrong S, Nascimento MM, Novy BB, Tinanoff N, Weyant RJ, Wolff MS, Young DA, Zero DT, Tampi MP, Pilcher L, Banfield L, Carrasco-Labra A. Evidence-based clinical practice guideline on nonrestorative treatments for carious lesions: A report from the American Dental Association. J Am Dent Assoc. 2018 Oct;149(10):837-849.e19. doi: 10.1016/j.adaj.2018.07.002.
- Background: PubMed 27470525Wright 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.
- Background: PubMed 30931743Gao 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.
- Background: PubMed 28346861Kind 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.
- Background: PubMed 31351196Saha 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.
- Background: PubMed 32321955Welk 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.
- Background: PubMed 31037343Broseler 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.
- Background: PubMed 32144336Doberdoli 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.
- Individual participant dataSharing planned: No. Study data will be deidentified and stored on a secure server. There will be no plans to release individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J Skaret, BS principal investigator
CareQuest Innovation Partners
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Initial Caries and Arrested Dental Caries, run by CareQuest Institute for Oral Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of CRFP compared to other tooth specific treatments in preventing progression to cavitation. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04933331, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.