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The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.
This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprinity | Experimental | Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate PCRs |
|
| e.max | Active Comparator | IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vita Suprinity | Other | zirconia reinforced lithium silicate partial coverage restorations |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Absolute failure is defined by clinical unacceptable fracture and crack development which required a replacement of the entire restoration, and/or secondary caries as well as endodontic complications | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Restorations with Marginal gap as assessed visually by US public health service criteria | restorations with visually detectable margin, catch or penetration of explorer at baseline or a change from baseline on visual analogue scale at 12 month | 12 month |
| Restorations with Marginal discoloration as assessed visually by US public health service criteria |
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Inclusion Criteria:
Teeth:
Exclusion Criteria:
Teeth:
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| Name | Affiliation | Role |
|---|---|---|
| Hesham Katamish, PHD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine- Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19477570 | Background | Guess PC, Strub JR, Steinhart N, Wolkewitz M, Stappert CF. All-ceramic partial coverage restorations--midterm results of a 5-year prospective clinical splitmouth study. J Dent. 2009 Aug;37(8):627-37. doi: 10.1016/j.jdent.2009.04.006. Epub 2009 May 3. | |
| 17380803 | Background | Stappert CF, Guess PC, Chitmongkolsuk S, Gerds T, Strub JR. All-ceramic partial coverage restorations on natural molars. Masticatory fatigue loading and fracture resistance. Am J Dent. 2007 Feb;20(1):21-6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2022 | |
| Reset | Aug 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2022 | Aug 7, 2023 |
| ID | Term |
|---|---|
| C000621298 | VITA Suprinity |
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split-mouth design
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| IPS e.max |
| Other |
lithium disilicate partial coverage restorations |
|
restorations with visually detectable discoloration along margin at baseline or a change from baseline on visual analogue scale at 12 month |
| 12 month |
| Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria | restorations with visually detectable color mismatch with adjacent teeth at baseline or a change from baseline on visual analogue scale at 12 month | 12 month |
| Restorations with surface roughness as assessed tactilely by US public health service criteria | restorations with tactilely detectable rough surface at baseline or a change from baseline on visual analogue scale at 12 month | 12 month |
| Restorations developed secondary caries as assessed visually by US public health service criteria | restorations with visually detectable secondary caries at baseline or a change from baseline on visual analogue scale at 12 month | 12 month |
| 18006051 | Background | Guess PC, Stappert CF. Midterm results of a 5-year prospective clinical investigation of extended ceramic veneers. Dent Mater. 2008 Jun;24(6):804-13. doi: 10.1016/j.dental.2007.09.009. Epub 2007 Nov 19. |
| 27042362 | Background | Rinke S, Pabel AK, Rodiger M, Ziebolz D. Chairside Fabrication of an All-Ceramic Partial Crown Using a Zirconia-Reinforced Lithium Silicate Ceramic. Case Rep Dent. 2016;2016:1354186. doi: 10.1155/2016/1354186. Epub 2016 Mar 6. |
| 11819962 | Background | McDonald A. Preparation guidelines for full and partial coverage ceramic restorations. Dent Update. 2001 Mar;28(2):84-90. doi: 10.12968/denu.2001.28.2.84. |
| 18069370 | Background | Signore A, Benedicenti S, Covani U, Ravera G. A 4- to 6-year retrospective clinical study of cracked teeth restored with bonded indirect resin composite onlays. Int J Prosthodont. 2007 Nov-Dec;20(6):609-16. |
| 12186346 | Background | Edelhoff D, Sorensen JA. Tooth structure removal associated with various preparation designs for posterior teeth. Int J Periodontics Restorative Dent. 2002 Jun;22(3):241-9. |
| 18395785 | Background | Stappert CF, Chitmongkolsuk S, Silva NR, Att W, Strub JR. Effect of mouth-motion fatigue and thermal cycling on the marginal accuracy of partial coverage restorations made of various dental materials. Dent Mater. 2008 Sep;24(9):1248-57. doi: 10.1016/j.dental.2008.02.005. Epub 2008 Apr 18. |
| 22372380 | Background | Murgueitio R, Bernal G. Three-year clinical follow-up of posterior teeth restored with leucite-reinforced ips empress onlays and partial veneer crowns. J Prosthodont. 2012 Jul;21(5):340-5. doi: 10.1111/j.1532-849X.2011.00837.x. Epub 2012 Feb 28. |
| 23617385 | Background | Kois DE, Isvilanonda V, Chaiyabutr Y, Kois JC. Evaluation of fracture resistance and failure risks of posterior partial coverage restorations. J Esthet Restor Dent. 2013 Apr;25(2):110-22. doi: 10.1111/jerd.12018. Epub 2013 Mar 19. |
| 26971352 | Background | Vogl V, Hiller KA, Buchalla W, Federlin M, Schmalz G. Controlled, prospective, randomized, clinical split-mouth evaluation of partial ceramic crowns luted with a new, universal adhesive system/resin cement: results after 18 months. Clin Oral Investig. 2016 Dec;20(9):2481-2492. doi: 10.1007/s00784-016-1779-2. Epub 2016 Mar 12. |