NCT04914962

Brief Summary

The aim of this study is to evaluate the antagonist enamel wear of two processing options of Celtra duo crowns (polished and glaze fired) restoring posterior teeth in comparison with sound enamel wear at baseline and 6 months

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Status
unknown

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

May 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

May 29, 2021

Last Update Submit

June 3, 2021

Conditions

Keywords

ZLScrownsocclusal wearglass ceramicpolished vs glazed

Outcome Measures

Primary Outcomes (1)

  • antagonist enamel wear

    Intraoral digital scanner and superimposition software Mm3 intraoral scanning of enamel antagonist to determine amount of wear in Mm3

    6 months

Study Arms (2)

monolithic glazedcrowns

ACTIVE COMPARATOR

glazed Celtra due crowns

Other: glazed zirconium lithium silicate

monolithic polished crowns

EXPERIMENTAL

polished Celtra due crowns

Other: polished zirconium lithium silicate

Interventions

monolithic glazed crown

Also known as: glazed Celtra due
monolithic glazedcrowns

monolithic polishedcrowns

Also known as: polished Celtra due
monolithic polished crowns

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pt aged 21-60 years old, be able to read and sign the informed consent document.
  • Psychologically and physically able to withstand conventional dental procedures.
  • Patients needing posterior full coverage restorations
  • Patients with sound natural antagonists.
  • Have no active periodontal or pulpal diseases
  • Able to attend punctually for preplanned visits and evaluation.

You may not qualify if:

  • Patients with poor oral hygiene, high caries risk and uncooperative patients.
  • Pregnant women.
  • Psychiatric problems or unrealistic expectations.
  • Lack of opposing dentition in the area of interest.
  • Restored occlusal surface opposing the planned restoration.
  • The presence of a removable or fixed orthodontic appliance.
  • Patients with parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • De Angelis F, D'Arcangelo C, Maliskova N, Vanini L, Vadini M. Wear Properties of Different Additive Restorative Materials Used for Onlay/Overlay Posterior Restorations. Oper Dent. 2020 May/Jun;45(3):E156-E166. doi: 10.2341/19-115-L. Epub 2020 Feb 13.

    PMID: 32053459BACKGROUND
  • Mehta SB, Banerji S, Millar BJ, Suarez-Feito JM. Current concepts on the management of tooth wear: part 1. Assessment, treatment planning and strategies for the prevention and the passive management of tooth wear. Br Dent J. 2012 Jan 13;212(1):17-27. doi: 10.1038/sj.bdj.2011.1099.

    PMID: 22240686BACKGROUND
  • Dahl BL, Carlsson GE, Ekfeldt A. Occlusal wear of teeth and restorative materials. A review of classification, etiology, mechanisms of wear, and some aspects of restorative procedures. Acta Odontol Scand. 1993 Oct;51(5):299-311. doi: 10.3109/00016359309040581.

    PMID: 8279271BACKGROUND
  • Nazirkar GS, Patil SV, Shelke PP, Mahagaonkar P. Comparative evaluation of natural enamel wear against polished yitrium tetragonal zirconia and polished lithium disilicate - An in vivo study. J Indian Prosthodont Soc. 2020 Jan-Mar;20(1):83-89. doi: 10.4103/jips.jips_218_19. Epub 2020 Jan 27.

    PMID: 32089603BACKGROUND
  • Batson ER, Cooper LF, Duqum I, Mendonca G. Clinical outcomes of three different crown systems with CAD/CAM technology. J Prosthet Dent. 2014 Oct;112(4):770-7. doi: 10.1016/j.prosdent.2014.05.002. Epub 2014 Jun 28.

    PMID: 24980739BACKGROUND

MeSH Terms

Conditions

Tooth WearTooth Attrition

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Eman M Anwer, professor

    professor of fixed prosthodontics

    PRINCIPAL INVESTIGATOR
  • karim Abo Bakr Mohamed, PhD

    teacher of fixed prosthodontics

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patient will receive a restoration with superior function, esthetics, and excellent clinical performance
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

May 29, 2021

First Posted

June 7, 2021

Study Start

July 10, 2021

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

June 7, 2021

Record last verified: 2021-06