NCT03926676

Brief Summary

comparing nano hybrid composite blocks grandio blocks (VOCO) with ceramic blocks (Emax) in indirect restorations using modified USPH criteria (marginal integrity) to see if there will be a significant different between two blocks

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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 22, 2019

Last Update Submit

April 22, 2019

Conditions

the Clinical Performance of Indirect Restoration Fabricated From Nanohybrid Cad Cam Composite Blocks and Ceramic Blocks

Outcome Measures

Primary Outcomes (1)

  • marginal integrity

    Modified USPH criteria

    one year

Study Arms (2)

Grandio blocks

EXPERIMENTAL

Nano hybrid composite blocks

Other: grandio blocksOther: emax

E max

ACTIVE COMPARATOR

ceramic blocks

Other: grandio blocksOther: emax

Interventions

grandio blocksOTHER

nano hybrid composite blocks

E maxGrandio blocks
emaxOTHER

ceramic blocks

E maxGrandio blocks

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with badly broken vital teeth
  • good oral hygiene measures
  • young adults males or females
  • cooperative patients approving to participate in the study

You may not qualify if:

  • patients with compromised medical history
  • lack of compliance
  • severe medical condition
  • severe or active periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

Study Officials

  • shereen MO Hafez, phd

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

donia MA abd el moaty, bachelor

CONTACT

01220767085doniamahmoud17@gmail.com

aya MO adly, bachelor

CONTACT

01221528843adly_sweetdentist@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hamsa Ashraf Abd El Menam

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

January 1, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)