NCT04784676

Brief Summary

this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
terminated

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, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 3, 2021

Last Update Submit

March 3, 2021

Conditions

Keywords

randomized clinical trialinternal adaptationCAD/CAM composite restorationall ceramic restorationE-max CADCAD/CAM milling systemCAD/CADcompositeinlaysonlayscone beam CTCBCT

Outcome Measures

Primary Outcomes (1)

  • internal fit evaluation

    in millimeter

    on cast before delivery

Study Arms (2)

nanohybrid composite blocks

EXPERIMENTAL

nanohybrid composite CAD/CAM blocks

Other: restoration

ceramic blocks

ACTIVE COMPARATOR

ceramic CAD/CAM blocks emax

Other: restoration

Interventions

indirect restoration

ceramic blocksnanohybrid composite blocks

Eligibility Criteria

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

You may qualify if:

  • patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study

You may not qualify if:

  • patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Cairo University

Cairo, Please Select..., 11553, Egypt

Location

Related Publications (1)

  • Ibrahim SH, Amr H, Hassan AA, Elzohairy A. Internal fit evaluation of indirect restorations fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken teeth using cone beam CT (CBCT): double-blinded randomized clinical trial. Heliyon. 2022 May 19;8(5):e09466. doi: 10.1016/j.heliyon.2022.e09466. eCollection 2022 May.

Study Officials

  • Shereen H Ibrahim, PhD

    associate professor of conservative Dentistry, faculty of dentistry Cairo university Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
allocation concealment by opaque sealed envelopes, the participants and assessors were blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial parallel group, two arms, superiority trial, allocation ratio 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

April 1, 2019

Primary Completion

April 5, 2020

Study Completion

April 5, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations