NCT05337358

Brief Summary

In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration 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

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 13, 2022

Last Update Submit

April 13, 2022

Conditions

Clinical Performance

Keywords

Lithium dislocatefiber reinforced composite

Outcome Measures

Primary Outcomes (1)

  • clinical performance

    Using the modified United States Public Health Service criteria (Modified USPHS)- categorical

    2 years

Study Arms (2)

Lithium disilicate

ACTIVE COMPARATOR

The intervention will be: Prosthetic endocrown

Procedure: endocrown

Fiber reinforced composite

ACTIVE COMPARATOR

The intervention will be: Prosthetic endocrown

Procedure: endocrown

Interventions

endocrownPROCEDURE

endocrown

Fiber reinforced compositeLithium 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

RECRUITING

Study Officials

  • Sameh Sh Abou-steit, PhD

    Lecturer of Fixed Prosthodontics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameh Sh Abou-steit, PhD

CONTACT

01001891010samehabousteit@hotmail.com

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
Lecturer of fixed prosthodontics

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 20, 2022

Study Start

April 1, 2021

Primary Completion

April 11, 2023

Study Completion

April 11, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

EG(1)