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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE016755 | U.S. NIH Grant/Contract | View source | |
| 116358 |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The overall objective of this three-armed randomized clinical trial (RCT) is to determine the comparative efficacy of three treatments for hypersensitive noncarious cervical lesions (NCLs): chemoactive dentifrice use, dentin bonding agent (DBA) with sealing, and flowable resin-based composite restoration. The primary outcomes of this study are the reduction/elimination of hypersensitivity and the effect of treatment as measured by patient-reported outcomes. Secondary outcomes, as determined by laboratory evaluation of intraoral replicas of pre- and posttreatment NCL surfaces, are tubule occlusion, retention of resin coating, retention of restoration, and change in lesion size. Outcomes will be ascertained via the following specific aims:
Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.
Specific Aim 2: To recruit subjects with teeth with hypersensitive NCLs, measure baseline sensitivity and subject quality of life, administer one of three different treatments to each of three randomized groups of subjects, and determine immediate posttreatment hypersensitivity.
Specific Aim 3: To compare the degree of tubule occlusion before and after the three treatments and to associate these findings with posttreatment hypersensitivity, patient-reported outcomes, and restoration retention.
Treatment of NCLs remains controversial. Few studies have compared treatment methods or their financial implications. This RCT will determine the reduction of NCL hypersensitivity and patient-reported outcomes over a 6-month period for each of three different treatments. This will be the first practice-based research network RCT to combine objective clinical assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin tubule occlusion and lesion size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentifrice | Active Comparator | Chemoactive (remineralizing, neuroactive) dentifrice treatment |
|
| Sealant | Active Comparator | DBA/sealant application |
|
| Resin-based composite | Active Comparator | Restoration with a dentin bonding agent (DBA) and flowable resin-based composite |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoactive (remineralizing, neuroactive) dentifrice treatment | Other | Chemoactive (remineralizing, neuroactive) dentifrice treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups. | Baseline, 1, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the degree of tubule occlusion before and after the three treatments and to associate these findings with posttreatment hypersensitivity, patient-reported outcomes, and restoration retention. | Baseline, 1, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick A Curro, DMD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryann Lehmann, DDS | Darien | Connecticut | 06820 | United States | ||
| Ahmad Soolari, D.M.D. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | AASM (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine. | ||
| 2656768 | Background | Absi EG, Addy M, Adams D. Dentine hypersensitivity. The development and evaluation of a replica technique to study sensitive and non-sensitive cervical dentine. J Clin Periodontol. 1989 Mar;16(3):190-5. doi: 10.1111/j.1600-051x.1989.tb01639.x. | |
| 8482781 |
| Label | URL |
|---|---|
| PEARL Network website | View source |
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| Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F | Other | Self-etch DBA followed by a hydrophobic resin layer |
|
| Clearfil S3 Bond; Premise Flowable resin-based composite | Other | Restoration with a dentin bonding agent (DBA) and flowable resin-based composite |
|
| Potomac |
| Maryland |
| 20854 |
| United States |
| Oral Health Center | Southborough | Massachusetts | 01772 | United States |
| Scott B Schaffer, DMD | Clark | New Jersey | 07066 | United States |
| Gentle Dental Care, LLC | Edison | New Jersey | 08820 | United States |
| Dr. Howard Spielman | Plainsboro | New Jersey | 08536 | United States |
| Drs. Martin & Ferraiolo | Totowa | New Jersey | 07512 | United States |
| Cynthia Jetter, DMD | Voorhees Township | New Jersey | 08043 | United States |
| Bay Dental PC | Brooklyn | New York | 11229 | United States |
| Ying Wong, DDS | New York | New York | 10024 | United States |
| Martin Man, DMD | New York | New York | 10038 | United States |
| Kay T. Oen, DDS | Port Chester | New York | 10573 | United States |
| Janice K. Pliszczak, DDS | Syracuse | New York | 13215 | United States |
| Susan D. Bernstein, DDS | Cincinnati | Ohio | 45231 | United States |
| Dr. Jeannette Abboud-Niemczyk | Drexel Hill | Pennsylvania | 19026 | United States |
| Allan J Horowitz, DMD | King of Prussia | Pennsylvania | 19406 | United States |
| Dr. Julie Ann Barna | Lewisburg | Pennsylvania | 17837 | United States |
| Background |
| Bader JD, Levitch LC, Shugars DA, Heymann HO, McClure F. How dentists classified and treated non-carious cervical lesions. J Am Dent Assoc. 1993 May;124(5):46-54. doi: 10.14219/jada.archive.1993.0112. |
| 8871039 | Background | Bader JD, McClure F, Scurria MS, Shugars DA, Heymann HO. Case-control study of non-carious cervical lesions. Community Dent Oral Epidemiol. 1996 Aug;24(4):286-91. doi: 10.1111/j.1600-0528.1996.tb00861.x. |
| 16567549 | Background | Bartlett DW, Shah P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. J Dent Res. 2006 Apr;85(4):306-12. doi: 10.1177/154405910608500405. |
| 7664969 | Background | Burke FJ, Whitehead SA, McCaughey AD. Contemporary concepts in the pathogenesis of the Class V non-carious lesion. Dent Update. 1995 Jan-Feb;22(1):28-32. |
| 16495872 | Background | Ceruti P, Menicucci G, Mariani GD, Pittoni D, Gassino G. Non carious cervical lesions. A review. Minerva Stomatol. 2006 Jan-Feb;55(1-2):43-57. English, Italian. |
| 15089941 | Background | Duran I, Sengun A. The long-term effectiveness of five current desensitizing products on cervical dentine sensitivity. J Oral Rehabil. 2004 Apr;31(4):351-6. doi: 10.1046/j.1365-2842.2003.01241.x. |
| 15025657 | Background | Gillam DG, Newman HN, Davies EH, Bulman JS, Troullos ES, Curro FA. Clinical evaluation of ferric oxalate in relieving dentine hypersensitivity. J Oral Rehabil. 2004 Mar;31(3):245-50. doi: 10.1046/j.0305-182X.2003.01230.x. |
| 9565278 | Background | Ide M, Morel AD, Wilson RF, Ashley FP. The role of a dentine-bonding agent in reducing cervical dentine sensitivity. J Clin Periodontol. 1998 Apr;25(4):286-90. doi: 10.1111/j.1600-051x.1998.tb02442.x. |
| 16296439 | Background | Kakaboura A, Rahiotis C, Thomaidis S, Doukoudakis S. Clinical effectiveness of two agents on the treatment of tooth cervical hypersensitivity. Am J Dent. 2005 Aug;18(4):291-5. |
| 1920008 | Background | Kerns DG, Scheidt MJ, Pashley DH, Horner JA, Strong SL, Van Dyke TE. Dentinal tubule occlusion and root hypersensitivity. J Periodontol. 1991 Jul;62(7):421-8. doi: 10.1902/jop.1991.62.7.421. |
| 7962894 | Background | Levitch LC, Bader JD, Shugars DA, Heymann HO. Non-carious cervical lesions. J Dent. 1994 Aug;22(4):195-207. doi: 10.1016/0300-5712(94)90107-4. |
| 14619725 | Background | LittleStar ML, Summitt JB. Non-carious cervical lesions: an evidenced-based approach to their diagnosis. Tex Dent J. 2003 Oct;120(10):972-80. No abstract available. |
| 10773637 | Background | Lussi A, Schaffner M. Progression of and risk factors for dental erosion and wedge-shaped defects over a 6-year period. Caries Res. 2000 Mar-Apr;34(2):182-7. doi: 10.1159/000016587. |
| 9553890 | Background | Lyttle HA, Sidhu N, Smyth B. A study of the classification and treatment of noncarious cervical lesions by general practitioners. J Prosthet Dent. 1998 Mar;79(3):342-6. doi: 10.1016/s0022-3913(98)70248-3. |
| Background | Miller E, Deleger S, Murphy J (2002). Implementing and managing adaptive designs for clinical trials. http://www.pharmaceutical-int.com/categories/interactive-clinical-technologies-inc/implementing-and-managing-adaptive-designs-for-clinical-trials.asp. |
| 12670064 | Background | American Academy of Operative Dentistry. Non-carious cervical lesions. Recommendations for clinical practice. Oper Dent. 2003 Mar-Apr;28(2):109-13. No abstract available. |
| 17692596 | Background | Ommerborn MA, Schneider C, Giraki M, Schafer R, Singh P, Franz M, Raab WH. In vivo evaluation of noncarious cervical lesions in sleep bruxism subjects. J Prosthet Dent. 2007 Aug;98(2):150-8. doi: 10.1016/S0022-3913(07)60048-1. |
| 10858746 | Background | Osborne-Smith KL, Burke FJ, Wilson NH. The aetiology of the non-carious cervical lesion. Int Dent J. 1999 Jun;49(3):139-43. doi: 10.1002/j.1875-595x.1999.tb00898.x. |
| 18051003 | Background | Pamir T, Dalgar H, Onal B. Clinical evaluation of three desensitizing agents in relieving dentin hypersensitivity. Oper Dent. 2007 Nov-Dec;32(6):544-8. doi: 10.2341/07-5. |
| 11949798 | Background | Prati C, Cervellati F, Sanasi V, Montebugnoli L. Treatment of cervical dentin hypersensitivity with resin adhesives: 4-week evaluation. Am J Dent. 2001 Dec;14(6):378-82. |
| 16459447 | Background | Rees JS. The biomechanics of abfraction. Proc Inst Mech Eng H. 2006 Jan;220(1):69-80. doi: 10.1243/095441105X69141. |
| 8613556 | Background | Rimondini L, Baroni C, Carrassi A. Ultrastructure of hypersensitive and non-sensitive dentine. A study on replica models. J Clin Periodontol. 1995 Dec;22(12):899-902. doi: 10.1111/j.1600-051x.1995.tb01792.x. |
| 15241912 | Background | Tavss EA, Fisher SW, Campbell S, Bonta Y, Darcy-Siegel J, Blackwell BL, Volpe AR, Miller SE. The scientific rationale and development of an optimized dentifrice for the treatment of dentin hypersensitivity. Am J Dent. 2004 Feb;17(1):61-70. |
| 11323828 | Background | Telles D, Pegoraro LF, Pereira JC. Prevalence of noncarious cervical lesions and their relation to occlusal aspects: a clinical study. J Esthet Dent. 2000;12(1):10-5. doi: 10.1111/j.1708-8240.2000.tb00193.x. |
| 2197128 | Background | Trowbridge HO, Silver DR. A review of current approaches to in-office management of tooth hypersensitivity. Dent Clin North Am. 1990 Jul;34(3):561-81. |
| 7661762 | Background | Tyas MJ. The Class V lesion--aetiology and restoration. Aust Dent J. 1995 Jun;40(3):167-70. doi: 10.1111/j.1834-7819.1995.tb05631.x. |
| 15367193 | Background | Yates RJ, Newcombe RG, Addy M. Dentine hypersensitivity: a randomised, double-blind placebo-controlled study of the efficacy of a fluoride-sensitive teeth mouthrinse. J Clin Periodontol. 2004 Oct;31(10):885-9. doi: 10.1111/j.1600-051X.2004.00581.x. |
| 17233322 | Background | Zantner C, Popescu O, Martus P, Kielbassa AM. Randomized clinical study on the efficacy of a new lacquer for dentine hypersensitivity. Schweiz Monatsschr Zahnmed. 2006;116(12):1232-7. |
| 8468624 | Background | Johansson A, Haraldson T, Omar R, Kiliaridis S, Carlsson GE. A system for assessing the severity and progression of occlusal tooth wear. J Oral Rehabil. 1993 Mar;20(2):125-31. doi: 10.1111/j.1365-2842.1993.tb01596.x. |
| Background | Lavigne GJ, Manzini C, Kato T (2005). Sleep Bruxism. In: Principles and practice of sleep medicine. MH Kryger, T Roth and WC Dement editors. Philadelphia: Elsevier, pp. 946-59 |
| 22699662 | Derived | Curro FA, Vena D, Naftolin F, Terracio L, Thompson VP. The PBRN initiative: transforming new technologies to improve patient care. J Dent Res. 2012 Jul;91(7 Suppl):12S-20S. doi: 10.1177/0022034512447948. |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C505694 | Clearfil S3 Bond |
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