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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE016755 | U.S. NIH Grant/Contract | View source | |
| 136277 | Other Grant/Funding Number | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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Postoperative hypersensitivity (POH) is a problem for many patients as determined by the recent Practitioners Engaged in Applied Research and Learning (PEARL) study of POH following occlusal caries restoration. The objectives of this two-armed randomized comparative effectiveness research trial (RCERT) are to determine whether adding a resin modified glass ionomer liner (RMGI) reduces POH in dentin bonded Class I resin based composite (RBC) restorations, and to identify other factors (putative risk factors) that are associated with increased POH.
The primary outcome of this study is the reduction/elimination of restoration POH as measured by clinical assessment (air stream) and patient-reports.
Outcomes will be ascertained via the following specific aims:
Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by clinical measurement (air drying) and by patient-reported outcomes among the two treatment groups at three points in time: prior to restoration and at one and four weeks postrestoration.
Specific Aim 2: To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed American Dental Association (ADA) Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restoration with a dentin bonding agent (DBA) | Active Comparator | Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions. |
|
| Restoration with a resin modified glass ionomer liner (RMGI) | Active Comparator | Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restoration with a dentin bonding agent (DBA) | Procedure | Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypersensitivity | To compare the reduction of hypersensitivity of study teeth by clinical measurement (air drying) and by patient-reported outcomes among the two treatment groups at three points in time: prior to restoration and at one and four weeks postrestoration. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative caries stage | To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status. | Baseline |
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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 |
|---|---|---|---|---|---|---|
| Phoenix Pediatric Dental | Phoeniz | Arizona | 85015 | United States | ||
| Watson and Niven Dental Partnership |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Academy of Sleep Medicine (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine. | ||
| 11806478 | Background | Akpata ES, Sadiq W. Post-operative sensitivity in glass-ionomer versus adhesive resin-lined posterior composites. Am J Dent. 2001 Feb;14(1):34-8. | |
| 16838478 |
| Label | URL |
|---|---|
| PEARL Network website | View source |
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|
| Restoration with a resin modified glass ionomer liner (RMGI) | Procedure | Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC). |
|
| Lesion depth | To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status. | Baseline |
| Dentin caries activity | To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status. | Baseline |
| Preparation depth | To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status. | Baseline |
| Sleep bruxism status | To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed ADA Caries Classification System (CCS), lesion depth as measured on the preoperative radiograph, dentin caries activity ranked on opening the lesion, preparation depth, and patient sleep bruxism status. | Baseline |
| Newport Beach |
| California |
| 92660 |
| United States |
| Jana A. Ikeda, DDS, PC | Boulder | Colorado | 80305 | United States |
| Maryann Lehmann, D.D.S. | Darien | Connecticut | 06820 | United States |
| Oracare Research | Sanford | Florida | 32771 | United States |
| Complete Dental Arts, P.C. | Newnan | Georgia | 30265 | United States |
| Creative Smiles Dental Care | Champaign | Illinois | 61820 | United States |
| Peggy Richardson, DDS, MS | Tinley Park | Illinois | 60477 | United States |
| Kokomo Oral Implantology | Kokomo | Indiana | 46901 | United States |
| Corridor Kids Pediatric Dentistry | North Liberty | Iowa | 52317 | United States |
| Community Dental - Biddeford Center | Biddeford | Maine | 04005 | United States |
| Cheryl F, Callahan, DDS, PA | Rockville | Maryland | 20850 | United States |
| Oral Medicine - Tufts School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
| Frank A Dahlstrom,DMD,PC | Dennis | Massachusetts | 02638 | United States |
| Oral Health Center | Southborough | Massachusetts | 01772 | United States |
| Small Smiles Dental Center of Springfield, LLC | Springfield | Massachusetts | 01128 | United States |
| Keith A Hudson DDS PC | Franklin | Michigan | 48025 | United States |
| Minnesota Dentalcare | Richfield | Minnesota | 55423 | United States |
| Eric Hirschfeld, D.D.S. | Conway | New Hampshire | 03818 | United States |
| Bordentown Family Dental | Bordentown | New Jersey | 08505 | 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 |
| Barry G. Dale, DMD | Tenafly | New Jersey | 07670 | United States |
| Cynthia Jetter, DMD | Voorhees Township | New Jersey | 08043 | United States |
| Bay Dental PC | Brooklyn | New York | 11229 | United States |
| Eric Leibowitz DDS | Brooklyn | New York | 11230 | United States |
| Queens Comprehensive Dental Services | Forest Hills | New York | 11375 | United States |
| Gilberto Nunez DDS LLC | Kingston | New York | 12401 | United States |
| Kay T. Oen, DDS | Port Chester | New York | 10573 | United States |
| East Avenue Dentistry PLLC | Rochester | New York | 14610 | United States |
| James R. Keenan, DDS, PC | Rockaway Beach | New York | 11693 | United States |
| Janice K. Pliszczak, DDS | Syracuse | New York | 13215 | United States |
| Susan D. Bernstein, DDS | Cincinnati | Ohio | 45231 | United States |
| Laurence H Stone, DDS | Doylestown | Pennsylvania | 18902 | 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 |
| Salvation Army Dental Center | Oil City | Pennsylvania | 16301 | United States |
| Elizabeth W. Galloway | Hilton Head Island | South Carolina | 29928 | United States |
| MEHOP | Bay City | Texas | 77414 | United States |
| Background |
| Akpata ES, Behbehani J. Effect of bonding systems on post-operative sensitivity from posterior composites. Am J Dent. 2006 Jun;19(3):151-4. |
| 19192831 | Background | Auschill TM, Koch CA, Wolkewitz M, Hellwig E, Arweiler NB. Occurrence and causing stimuli of postoperative sensitivity in composite restorations. Oper Dent. 2009 Jan-Feb;34(1):3-10. doi: 10.2341/08-7. |
| 11831309 | Background | Baratieri LN, Ritter AV. Four-year clinical evaluation of posterior resin-based composite restorations placed using the total-etch technique. J Esthet Restor Dent. 2001;13(1):50-7. doi: 10.1111/j.1708-8240.2001.tb00251.x. |
| 17910217 | Background | Briso AL, Mestrener SR, Delicio G, Sundfeld RH, Bedran-Russo AK, de Alexandre RS, Ambrosano GM. Clinical assessment of postoperative sensitivity in posterior composite restorations. Oper Dent. 2007 Sep-Oct;32(5):421-6. doi: 10.2341/06-141. |
| 17427818 | Background | Browning WD, Blalock JS, Callan RS, Brackett WW, Schull GF, Davenport MB, Brackett MG. Postoperative sensitivity: a comparison of two bonding agents. Oper Dent. 2007 Mar-Apr;32(2):112-7. doi: 10.2341/06-58. |
| 16536346 | Background | Casselli DS, Martins LR. Postoperative sensitivity in Class I composite resin restorations in vivo. J Adhes Dent. 2006 Feb;8(1):53-8. |
| 12022463 | Background | Cho BH, Dickens SH, Bae JH, Chang CG, Son HH, Um CM. Effect of interfacial bond quality on the direction of polymerization shrinkage flow in resin composite restorations. Oper Dent. 2002 May-Jun;27(3):297-304. |
| 11868844 | Background | Christensen GJ. Preventing postoperative tooth sensitivity in class I, II and V restorations. J Am Dent Assoc. 2002 Feb;133(2):229-31. doi: 10.14219/jada.archive.2002.0149. |
| 16708724 | Background | Efes BG, Dorter C, Gomec Y, Koray F. Two-year clinical evaluation of ormocer and nanofill composite with and without a flowable liner. J Adhes Dent. 2006 Apr;8(2):119-26. |
| 11642558 | Background | Ernst CP, Martin M, Stuff S, Willershausen B. Clinical performance of a packable resin composite for posterior teeth after 3 years. Clin Oral Investig. 2001 Sep;5(3):148-55. doi: 10.1007/s007840100117. |
| 16555069 | Background | Ernst CP, Brandenbusch M, Meyer G, Canbek K, Gottschalk F, Willershausen B. Two-year clinical performance of a nanofiller vs a fine-particle hybrid resin composite. Clin Oral Investig. 2006 Jun;10(2):119-25. doi: 10.1007/s00784-006-0041-8. Epub 2006 Mar 23. |
| 12413217 | Background | Gordan VV, Mjor IA. Short- and long-term clinical evaluation of post-operative sensitivity of a new resin-based restorative material and self-etching primer. Oper Dent. 2002 Nov-Dec;27(6):543-8. |
| 14653280 | Background | Hayashi M, Wilson NH. Failure risk of posterior composites with post-operative sensitivity. Oper Dent. 2003 Nov-Dec;28(6):681-8. |
| 17472181 | Background | Kaurani M, Bhagwat SV. Clinical evaluation of postoperative sensitivity in composite resin restorations using various liners. N Y State Dent J. 2007 Mar;73(2):23-9. |
| 2659634 | Background | Letzel H. Survival rates and reasons for failure of posterior composite restorations in multicentre clinical trial. J Dent. 1989;17 Suppl 1:S10-7; discussion S26-8. doi: 10.1016/0300-5712(89)90156-5. |
| Background | Liang K-Y, Zeger SL (1986). Longitudinal data analysis using generalized linear models. Biometrika 73:13-22. |
| 15471000 | Background | Lundin SA, Rasmusson CG. Clinical evaluation of a resin composite and bonding agent in Class I and II restorations: 2-year results. Quintessence Int. 2004 Oct;35(9):758-62. |
| 15451239 | Background | Miguez PA, Pereira PN, Foxton RM, Walter R, Nunes MF, Swift EJ Jr. Effects of flowable resin on bond strength and gap formation in Class I restorations. Dent Mater. 2004 Nov;20(9):839-45. doi: 10.1016/j.dental.2003.10.015. |
| 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. |
| 10388382 | Background | Opdam NJ, Feilzer AJ, Roeters JJ, Smale I. Class I occlusal composite resin restorations: in vivo post-operative sensitivity, wall adaptation, and microleakage. Am J Dent. 1998 Oct;11(5):229-34. |
| 14719760 | Background | Perdigao J, Geraldeli S, Hodges JS. Total-etch versus self-etch adhesive: effect on postoperative sensitivity. J Am Dent Assoc. 2003 Dec;134(12):1621-9. doi: 10.14219/jada.archive.2003.0109. |
| 15553285 | Background | Perdigao J, Anauate-Netto C, Carmo AR, Hodges JS, Cordeiro HJ, Lewgoy HR, Dutra-Correa M, Castilhos N, Amore R. The effect of adhesive and flowable composite on postoperative sensitivity: 2-week results. Quintessence Int. 2004 Nov-Dec;35(10):777-84. |
| 17542208 | Background | Perdigao J, Dutra-Correa M, Castilhos N, Carmo AR, Anauate-Netto C, Cordeiro HJ, Amore R, Lewgoy HR. One-year clinical performance of self-etch adhesives in posterior restorations. Am J Dent. 2007 Apr;20(2):125-33. |
| 19492717 | Background | Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59. |
| 12673433 | Background | Rosin M, Steffen H, Konschake C, Greese U, Teichmann D, Hartmann A, Meyer G. One-year evaluation of an Ormocer restorative-a multipractice clinical trial. Clin Oral Investig. 2003 Mar;7(1):20-6. doi: 10.1007/s00784-002-0189-9. Epub 2003 Feb 4. |
| 20202097 | Background | Sadeghi M, Lynch CD, Shahamat N. Eighteen-month clinical evaluation of microhybrid, packable and nanofilled resin composites in Class I restorations. J Oral Rehabil. 2010 Jul;37(7):532-7. doi: 10.1111/j.1365-2842.2010.02073.x. Epub 2010 Feb 25. |
| 16102079 | Background | Sobral MA, Garone-Netto N, Luz MA, Santos AP. Prevention of postoperative tooth sensitivity: a preliminary clinical trial. J Oral Rehabil. 2005 Sep;32(9):661-8. doi: 10.1111/j.1365-2842.2005.01479.x. |
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| 15892534 | Background | Turkun LS, Turkun M, Ozata F. Clinical performance of a packable resin composite for a period of 3 years. Quintessence Int. 2005 May;36(5):365-72. |
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| 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 |
|---|---|
| D003731 | Dental Caries |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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