Early Caries Lesion Management Observational Study

Dental Caries Clinical Trial

— ELMO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04933331
• Other study ID #: DQCI003
• Status: Active, not recruiting
• Start date: December 7, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: CareQuest Institute for Oral Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 744
• Est. completion date: March 31, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Primary teeth

• Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions

• Healthy/ ADACCS "Sound" teeth

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Heart Arrest

Intervention

Drug:
• 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.

Device:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Advantage Dental Oral Health Center	Bend	Oregon
United States	Community Dental Care	Dallas	Texas
United States	Sarrell Dental Clinic	Dothan	Alabama
United States	DentaQuest (Advantage Dental) Oral Health Center	Westborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CareQuest Institute for Oral Health

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Jackson 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. — View Citation

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. — View Citation

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. — View Citation

Seirawan 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. — View Citation

Slayton 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the effectiveness of SDF compared to no tooth specific treatment (including whole mouth treatment) on caries arrest in patients with at least one early dental lesion.	The percentage of lesions treated with SDF that have caries arrest for at least one early lesion noted at baseline during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of SDF (silver diamine fluoride) compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.	The percentage of lesions treated with SDF that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of sealants compared to no tooth specific treatment (including whole mouth treatment) in preventing progression to cavitation.	The percentage of lesions treated with sealants that require operative treatment for at least one early lesion noted at baseline during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of CRFP compared to sealants in preventing progression to cavitation.	The percentage of lesions treated with CRFP that require operative treatment compared to those treated with sealants during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of CRFP compared to SDF in preventing progression to cavitation.	The percentage of lesions treated with CRFP that require operative treatment compared to those treated with SDF during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of CRFP compared to SDF (silver diamine fluoride) on caries arrest in patients with at least one early dental lesion.	The percentage of lesions treated with CRFP that have caries arrest compared to those treated with SDF that have caries arrest during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of sealants compared to SDF (silver diamine fluoride) in preventing progression to cavitation in patients with at least one early dental lesion.	The percentage of lesions treated with SDF that require operative treatment compared to those treated with sealants during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Other	To assess the effectiveness of tooth specific treatments in patients who are actively undergoing orthodontic care and have at least one early dental lesion.	A comparison of lesions that have caries arrest or require operative treatment for early lesion interventions during the 24 months of observation from baseline.	Baseline, 6 months, 12 months, 18 months, 24 months
Primary	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.	24 months
Secondary	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Secondary	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.	Baseline, 6 months, 12 months, 18 months, 24 months