Primary Molars Restoration Using Different Pediatric Crowns. | NCT04144062

Studies
Primary Molars Restoration Using Different Pediatric Crowns.

NCT04144062

Sponsor

Nehal Salman

Status

Completed

Last Update Posted

May 14, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Restoration of Primary Molars With CAD/CAM Crowns

Interventions

CAD/CAM crowns

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2021Actual

Primary Completion Date

Nov 25, 2022Actual

Completion Date

Nov 25, 2022Actual

First Submitted Date

Oct 28, 2019

First Submission Date that Met QC Criteria

Oct 28, 2019

First Posted Date

Oct 30, 2019Actual

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

May 10, 2025

Last Update Posted Date

May 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia ans stainless steel crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; crown retention, stain resistance and periodontal and gingival health as well as parental/child satisfaction.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Zirconia crowns	Active Comparator	Other: CAD/CAM crowns
CAD/CAM crowns	Active Comparator	Other: CAD/CAM crowns
Stainless-steel crowns	Active Comparator	Other: CAD/CAM crowns

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAD/CAM crowns	Other	CAD/CAM crowns	CAD/CAM crowns Stainless-steel crowns Zirconia crowns

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical success	United States Public Health Service (USPHS) index	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range of the patients from 5 to 8 years old.
Have no history of spontaneous pain or swelling.
Patients willing to return for follow-up examinations and evaluation.
Medically free patients or with controlled systemic disease ASA I or II.
No active periodontal diseases.
Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Exclusion Criteria:

Children with intellectual, severe emotional or behavioral problems.
Presence of parafunctional habits such as clenching or bruxism.
Abnormal tooth mobility, gingival swelling, fistulous tract, or non-vital pulps.
Non-restorable teeth.
Radiographic positive signs of thickened or interrupted periodontal membrane space, internal root resorption, periapical or furcal radiolucency

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nehal Salman		Alexandria	Egypt	21648	Egypt