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This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions
With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservation of the demineralized chalky white enamel margin of class V cavities | Experimental | for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration |
|
| Total removal of demineralized enamel margin of class V cavities | Active Comparator | for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conserved chalky white enamel margins of class V cavities | Procedure | during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria |
| Measure | Description | Time Frame |
|---|---|---|
| marginal discoloration | ordinal criteria scoring system (ordinal) | 3 months |
| marginal discoloration | ordinal criteria scoring system (ordinal) | 6 months |
| marginal discoloration | ordinal criteria scoring system (ordinal) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| color change | ordinal criteria scoring system (ordinal) | 3 month |
| color change | ordinal criteria scoring system (ordinal) | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryam Salim Dawood, master | Contact | 00201011270500 | maryam.salim@dentistry.cu.edu.eg | |
| Mohamed Refaat El-Bialy, PHD | Contact | 00201202552666 | mohamed.refaat@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Cairo University | Recruiting | Cairo | 11511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17467137 | Background | Abdalla AI, Garcia-Godoy F. Clinical performance of a self-etch adhesive in Class V restorations made with and without acid etching. J Dent. 2007 Jul;35(7):558-63. doi: 10.1016/j.jdent.2007.02.006. Epub 2007 Apr 27. | |
| 29116298 | Background | Alexandria AK, Nassur C, Nobrega CBC, Valenca AMG, Rosalen PL, Maia LC. In situ effect of titanium tetrafluoride varnish on enamel demineralization. Braz Oral Res. 2017 Nov 6;31:e86. doi: 10.1590/1807-3107BOR-2017.vol31.0086. |
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1:1
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Participant and Outcomes Assessor
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| Total removal of demineralized enamel margins of class V cavities | Procedure | during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria |
|
| color change | ordinal criteria scoring system (ordinal) | 12 month |
| 16421996 | Background | Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available. |
| 16231497 | Background | Baratieri LN, Ritter AV. Critical appraisal. To bevel or not in anterior composites. J Esthet Restor Dent. 2005;17(4):264-9. doi: 10.1111/j.1708-8240.2005.tb00126.x. |
| 23452972 | Background | Chen H, Liu X, Dai J, Jiang Z, Guo T, Ding Y. Effect of remineralizing agents on white spot lesions after orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):376-382.e3. doi: 10.1016/j.ajodo.2012.10.013. |
| 28621326 | Background | Kielbassa AM, Ulrich I, Schmidl R, Schuller C, Frank W, Werth VD. Resin infiltration of deproteinised natural occlusal subsurface lesions improves initial quality of fissure sealing. Int J Oral Sci. 2017 Jun;9(2):117-124. doi: 10.1038/ijos.2017.15. Epub 2017 Jun 16. |
| 29152623 | Background | Korner P, El Gedaily M, Attin R, Wiedemeier DB, Attin T, Taubock TT. Margin Integrity of Conservative Composite Restorations after Resin Infiltration of Demineralized Enamel. J Adhes Dent. 2017;19(6):483-489. doi: 10.3290/j.jad.a39280. |
| 20582219 | Background | Lata S, Varghese NO, Varughese JM. Remineralization potential of fluoride and amorphous calcium phosphate-casein phospho peptide on enamel lesions: An in vitro comparative evaluation. J Conserv Dent. 2010 Jan;13(1):42-6. doi: 10.4103/0972-0707.62634. |
| 32902766 | Background | Koc Vural U, Kerimova L, Kiremitci A. Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial. Odontology. 2021 Apr;109(2):376-384. doi: 10.1007/s10266-020-00550-8. Epub 2020 Sep 9. |
| 33562810 | Background | Brkanovic S, Ivanisevic A, Miletic I, Mezdic D, Jukic Krmek S. Effect of Nano-Filled Protective Coating and Different pH Enviroment on Wear Resistance of New Glass Hybrid Restorative Material. Materials (Basel). 2021 Feb 5;14(4):755. doi: 10.3390/ma14040755. |