NCT04563624

Brief Summary

The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks

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
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2020

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

September 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

September 20, 2020

Last Update Submit

September 24, 2020

Conditions

Teeth Restoration

Outcome Measures

Primary Outcomes (1)

  • marginal integrity

    using usphs visual inspection

    one year

Study Arms (2)

ceramic cad cam blocks

EXPERIMENTAL
Drug: ceramic cad cam blocks

composite cad cam blocks

ACTIVE COMPARATOR
Drug: composite blocks

Interventions

composite blocksDRUG

cad cam composite blocks

composite cad cam blocks
ceramic cad cam blocksDRUG

ceramic cad cam blocks

ceramic cad cam blocks

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with badly broken vital teeth
  • Young adult Males or female
  • Good oral hygiene measures
  • Cooperative patients approving to participate in the study

You may not qualify if:

  • Patients with a compromised medical history.
  • Severe or active periodontal disease
  • Severe medical complications
  • Lack of compliance
  • Endodontically treated teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elmoselhy HAS, Hassanien OES, Haridy MF, Salam El Baz MAE, Saber S. Two-year clinical performance of indirect restorations fabricated from CAD/CAM nano hybrid composite versus lithium disilicate in mutilated vital teeth. A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):101. doi: 10.1186/s12903-023-03847-6.

    PMID: 38233771DERIVED

Central Study Contacts

HANEEN ELMOSELHY, mastrers

CONTACT

01003778829haneen.elmoselhy@bue.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer in the operative department

Study Record Dates

First Submitted

September 20, 2020

First Posted

September 24, 2020

Study Start

October 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

September 28, 2020

Record last verified: 2020-09