NCT03328572

Brief Summary

  1. 1.RATIONALE All-ceramic endocrowns are bonded to the tooth using adhesive resins creating strong bonds to the tooth structure resulting in strengthening effect and reducing the need for post and core. various CAD/CAM materials can be used for the fabrication of endocrowns including lithium-disilicate reinforced glass-ceramics, feldspathic ceramics, in ceram alumina and in ceram spinell as well as hybrid ceramics and composites.
  2. 2.OBJECTIVES P= Endodontically treated teeth indicated for endocrown I1= Feldspathic endocrown I2= Hybrid endocrown C= IPS e.max Endocrown O= Clinical performance

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

October 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

4.3 years

First QC Date

October 23, 2017

Last Update Submit

February 5, 2021

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (7)

  • Retention

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

  • Marginal adaptaion

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

  • Marginal discoloration

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

  • Anatomic form

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

  • Secomdary caries

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

  • Surface texture

    Modified USPHS

    6 months

  • Color match

    Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.

    6 months

Secondary Outcomes (3)

  • Modified Gingival bleeding index MGI

    6 months

  • Modified Periodontal Index

    6 months

  • Patient satisfaction

    6 months

Study Arms (2)

E-max Endocrowns

ACTIVE COMPARATOR

all patients in this arm will receive e-max endocrowns

Other: E-max Endocrown

Cerasmart Endocrowns

EXPERIMENTAL

all patients in this arm will receive Cerasmart endocrowns

Other: Cerasmart Endocrown

Interventions

E-max EndocrownOTHER

Endocrown preparation

E-max Endocrowns
Cerasmart EndocrownOTHER

Endocrown preparation

Cerasmart Endocrowns

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age range of the patients from 15-60 years old.
  • Patients able physically and psychologically to tolerate conventional restorative procedures.
  • Patients with endodontically treated molars.
  • Patients with adequate root canal treatment with good apical seal.
  • Presence of teeth in opposite arch with normal occlusion.
  • Supra-gingival margin after preparation.
  • One wall defect cavity.
  • Patients willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene and motivation.
  • Patients with parafunctional habits.
  • Patients with active periodontal or periapical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 12554, Egypt

RECRUITING

Related Publications (4)

  • Naumann M, Blankenstein F, Dietrich T. Survival of glass fibre reinforced composite post restorations after 2 years-an observational clinical study. J Dent. 2005 Apr;33(4):305-12. doi: 10.1016/j.jdent.2004.09.005. Epub 2004 Dec 10.

    PMID: 15781138BACKGROUND

  • Guo J, Wang Z, Li X, Sun C, Gao E, Li H. A comparison of the fracture resistances of endodontically treated mandibular premolars restored with endocrowns and glass fiber post-core retained conventional crowns. J Adv Prosthodont. 2016 Dec;8(6):489-493. doi: 10.4047/jap.2016.8.6.489. Epub 2016 Dec 15.

    PMID: 28018567BACKGROUND

  • Bitter K, Kielbassa AM. Post-endodontic restorations with adhesively luted fiber-reinforced composite post systems: a review. Am J Dent. 2007 Dec;20(6):353-60.

    PMID: 18269124BACKGROUND

  • 4. Moradpoor H, Raissi S. Survival Rate of Endodontically Treated Teeth with Fiber Posts after Prosthodontic Restoration: A Study Review. Sch J Dent Sci. 2017;4(2):43-

    BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Dr. Gihan El Nagar

    Professor, Fixed Prosthodontics department, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Dr. Gihan El Nagar, Professor

CONTACT

01006607978drgigielnagar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 1, 2017

Study Start

February 15, 2019

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

EG(1)