NCT06695091

Brief Summary

The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

September 12, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
2 years until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

5.3 years

First QC Date

November 29, 2022

Last Update Submit

November 17, 2024

Conditions

Clinical Behavioral

Keywords

Lithium disilicateZirconiaAll-ceramic crowns

Outcome Measures

Primary Outcomes (1)

  • Fracture

    Using Modified United States Public Health Service (USPHS) criteria

    12 months

Secondary Outcomes (3)

  • Marginal adaptation

    12 months

  • Marginal discoloration

    12 months

  • Secondary caries

    12 months

Study Arms (2)

Flat occlusal scheme

ACTIVE COMPARATOR

occlusal design

Procedure: Monolithic zirconia crownProcedure: Monolithic lithium disilicate crown

Anatomic occlusal scheme

ACTIVE COMPARATOR

occlusal design

Procedure: Monolithic zirconia crownProcedure: Monolithic lithium disilicate crown

Interventions

Monolithic zirconia crownPROCEDURE

All-ceramic crown

Anatomic occlusal schemeFlat occlusal scheme
Monolithic lithium disilicate crownPROCEDURE

All-ceramic crown

Anatomic occlusal schemeFlat occlusal scheme

Eligibility Criteria

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

You may qualify if:

  • Patients with posterior root canal treated teeth that require full coverage restoration.
  • years old.
  • Males or Females.
  • Good oral hygiene.
  • Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
  • Patients agreed to return to follow-up evaluation.

You may not qualify if:

  • Active periodontal or pulpal diseases.
  • Lack of opposing dentition.
  • Severe medical complications.
  • Pregnancy.
  • Lack of compliance.
  • Evidence of parafunctional habits
  • Temporomandibular joint disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (5)

  • Mannocci F, Cowie J. Restoration of endodontically treated teeth. Br Dent J. 2014 Mar;216(6):341-6. doi: 10.1038/sj.bdj.2014.198.

    PMID: 24651340BACKGROUND

  • Varlan C, Dimitriu B, Varlan V, Bodnar D, Suciu I. Current opinions concerning the restoration of endodontically treated teeth: basic principles. J Med Life. 2009 Apr-Jun;2(2):165-72.

    PMID: 20108535BACKGROUND

  • Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.

    PMID: 22259801BACKGROUND

  • Nagasiri R, Chitmongkolsuk S. Long-term survival of endodontically treated molars without crown coverage: a retrospective cohort study. J Prosthet Dent. 2005 Feb;93(2):164-70. doi: 10.1016/j.prosdent.2004.11.001.

    PMID: 15674228BACKGROUND

  • Oyar P, Ulusoy M, Eskitascioglu G. Finite element analysis of stress distribution in ceramic crowns fabricated with different tooth preparation designs. J Prosthet Dent. 2014 Oct;112(4):871-7. doi: 10.1016/j.prosdent.2013.12.019. Epub 2014 Apr 21.

    PMID: 24750896BACKGROUND

Study Officials

  • Sameh Abou-Steit, Lecturer

    Lecturer of Fixed Prosthodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Triple blinded: The trial participants, the outcome assessors and the data analysis statistician are blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of fixed prosthodontics

Study Record Dates

First Submitted

November 29, 2022

First Posted

November 19, 2024

Study Start

September 12, 2020

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations

EG(1)