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NCT04757428 Clinical Trial

Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns

Personal Satisfaction Clinical Trial

Official title:
Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns (Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04757428
Other study ID # CEBD-2019-3-080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2019
Est. completion date March 11, 2022

Study information
Verified date October 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare marginal adaptation, fracture, retention, shade matching and patient satisfaction between lithium disilicate (e.max) and hybrid nano-ceramic (Grandio) CAD/CAM endocrowns.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 11, 2022
Est. primary completion date March 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients with good oral hygiene - Patients having one or more endodontically treated molars that need prosthetic restoration. - Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival - Fully erupted molars - Molars free of developmental defect - Healthy periodontium - Absence of periapical pathosis - Acceptable endodontic treatment and proper bone support Exclusion Criteria: - Patients with bad oral hygiene - Patients with active periodontal disease - Patients with missing teeth opposing to the area intended for restoration - Patients with parafunctional habits or psychiatric problems or unrealistic expectation.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endocrown
Endocrown

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Belleflamme MM, Geerts SO, Louwette MM, Grenade CF, Vanheusden AJ, Mainjot AK. No post-no core approach to restore severely damaged posterior teeth: An up to 10-year retrospective study of documented endocrown cases. J Dent. 2017 Aug;63:1-7. doi: 10.1016/j.jdent.2017.04.009. Epub 2017 Apr 27. — View Citation

da Cunha LF, Gonzaga CC, Pissaia JF, Correr GM. Lithium silicate endocrown fabricated with a CAD-CAM system: A functional and esthetic protocol. J Prosthet Dent. 2017 Aug;118(2):131-134. doi: 10.1016/j.prosdent.2016.10.006. Epub 2017 Jan 13. — View Citation

da Fonseca GF, Dal Piva AM, Tribst JP, Borges AL. Influence of Restoration Height and Masticatory Load Orientation on Ceramic Endocrowns. J Contemp Dent Pract. 2018 Sep 1;19(9):1052-1057. — View Citation

Furtado de Mendonca A, Shahmoradi M, Gouvêa CVD, De Souza GM, Ellakwa A. Microstructural and Mechanical Characterization of CAD/CAM Materials for Monolithic Dental Restorations. J Prosthodont. 2019 Feb;28(2):e587-e594. doi: 10.1111/jopr.12964. Epub 2018 Aug 18. — View Citation

Otto T, Mörmann WH. Clinical performance of chairside CAD/CAM feldspathic ceramic posterior shoulder crowns and endocrowns up to 12 years. Int J Comput Dent. 2015;18(2):147-61. English, German. — View Citation

Rosentritt M, Preis V, Behr M, Hahnel S. Influence of preparation, fitting, and cementation on the vitro performance and fracture resistance of CAD/CAM crowns. J Dent. 2017 Oct;65:70-75. doi: 10.1016/j.jdent.2017.07.006. Epub 2017 Jul 19. — View Citation

Schaefer O, Watts DC, Sigusch BW, Kuepper H, Guentsch A. Marginal and internal fit of pressed lithium disilicate partial crowns in vitro: a three-dimensional analysis of accuracy and reproducibility. Dent Mater. 2012 Mar;28(3):320-6. doi: 10.1016/j.dental.2011.12.008. Epub 2012 Jan 21. — View Citation

Sedrez-Porto JA, Rosa WL, da Silva AF, Münchow EA, Pereira-Cenci T. Endocrown restorations: A systematic review and meta-analysis. J Dent. 2016 Sep;52:8-14. doi: 10.1016/j.jdent.2016.07.005. Epub 2016 Jul 12. Review. — View Citation

Shamseddine L, Mortada R, Rifai K, Chidiac JJ. Marginal and internal fit of pressed ceramic crowns made from conventional and computer-aided design and computer-aided manufacturing wax patterns: An in vitro comparison. J Prosthet Dent. 2016 Aug;116(2):242-8. doi: 10.1016/j.prosdent.2015.12.005. Epub 2016 Mar 3. — View Citation

Tribst JPM, Dal Piva AMO, Madruga CFL, Valera MC, Borges ALS, Bresciani E, de Melo RM. Endocrown restorations: Influence of dental remnant and restorative material on stress distribution. Dent Mater. 2018 Oct;34(10):1466-1473. doi: 10.1016/j.dental.2018.06.012. Epub 2018 Jun 21. — View Citation

Tzimas K, Tsiafitsa M, Gerasimou P, Tsitrou E. Endocrown restorations for extensively damaged posterior teeth: clinical performance of three cases. Restor Dent Endod. 2018 Aug 22;43(4):e38. doi: 10.5395/rde.2018.43.e38. eCollection 2018 Nov. — View Citation

Wang F, Yu T, Chen J. Biaxial flexural strength and translucent characteristics of dental lithium disilicate glass ceramics with different translucencies. J Prosthodont Res. 2020 Jan;64(1):71-77. doi: 10.1016/j.jpor.2019.04.007. Epub 2019 May 11. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Patient satisfaction Using Binary Visual Analogue scale (Satisfied/ not satisfied) 2 years
Secondary Shade matching Using the modified United States Public Health Service criteria (Modified USPHS)- categorical 2 years
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