Clinical Assessment of Indirect Restoration Fabricated Fr... | NCT04563624

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Estimated

Primary Completion Date

Nov 1, 2020Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Sep 20, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2020

Last Update Posted Date

Sep 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haneen ahmed shafik elmoselhy, assistant lecturer in the operative department, British University In EgyptPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ceramic cad cam blocks	Experimental		Drug: ceramic cad cam blocks
composite cad cam blocks	Active Comparator		Drug: composite blocks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
composite blocks	Drug	cad cam composite blocks	composite cad cam blocks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
marginal integrity	using usphs visual inspection	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HANEEN ELMOSELHY, mastrers	Contact	01003778829		haneen.elmoselhy@bue.edu.eg

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38233771	Derived	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.