NCT04757428

Brief Summary

the aim of this study was to evaluate the clinical performance of two CAD/CAM materials, hybrid nano-ceramic and lithium disilicate ceramic, in the fabrication of anterior endocrowns in patients with anterior endodontically treated teeth. While the postulated null hypothesis of this study was that there will be no significant difference between the performance of hybrid nanoceramic and lithium disilicate anterior endocrowns in patients with endodontically treated teeth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 11, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

January 31, 2021

Last Update Submit

July 3, 2024

Conditions

Personal Satisfaction

Keywords

Lithium disilicatehybrid ceramic

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Using Binary Visual Analogue scale (Satisfied/ not satisfied)

    2 years

Secondary Outcomes (1)

  • Shade matching

    2 years

Study Arms (2)

Lithium disilicate

ACTIVE COMPARATOR

The intervention will be: Prosthetic endocrown

Procedure: Endocrown

Hybrid nanoceramic

ACTIVE COMPARATOR

The intervention will be: Prosthetic endocrown

Procedure: Endocrown

Interventions

EndocrownPROCEDURE

Endocrown

Hybrid nanoceramicLithium disilicate

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (12)

  • 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.

    PMID: 28089332BACKGROUND

  • 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.

    PMID: 31088735BACKGROUND

  • 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.

    PMID: 28734997BACKGROUND

  • 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.

    PMID: 29935769BACKGROUND

  • 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.

    PMID: 30287703BACKGROUND

  • 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.

    PMID: 22265824BACKGROUND

  • 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.

    PMID: 26948080BACKGROUND

  • 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.

    PMID: 28456557BACKGROUND

  • 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.

    PMID: 30483462BACKGROUND

  • Sedrez-Porto JA, Rosa WL, da Silva AF, Munchow 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.

    PMID: 27421989BACKGROUND

  • Furtado de Mendonca A, Shahmoradi M, Gouvea 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.

    PMID: 30121945BACKGROUND

  • Otto T, Mormann 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.

    PMID: 26110927BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sameh Sh Abou-steit, PhD

    Lecturer of Fixed Prosthodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 17, 2021

Study Start

August 11, 2022

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

EG(1)