Evaluation of Revascularization of Failed Endodontically... | NCT05168553

Studies
Evaluation of Revascularization of Failed Endodontically Treated Mature Permanent Teeth

NCT05168553

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Dec 23, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Revascularization

Interventions

Revascualrization
Conventional endodontic treatment

Countries

Not provided

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

Dec 2021

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

Dec 12, 2021Estimated

Primary Completion Date

Dec 11, 2022Estimated

Completion Date

Dec 11, 2022Estimated

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

Dec 22, 2021

First Posted Date

Dec 23, 2021Actual

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

Dec 22, 2021

Last Update Posted Date

Dec 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Retraetment of failed previous endodontic treated mature permenant teeth with revascularization versus retreatment by conventional endodontic treatment

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Revasularization	Experimental		Other: Revascualrization
Conventional endodontic treatment	Active Comparator		Other: Conventional endodontic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Revascualrization	Other	Regain pulp vascularity for mature permenant teeth	Revasularization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical success	Number of participants with pain, mobility and/or fistulous tract (+/-)	1 year
Radiographic success	Absence of periapical radiolucency	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pescence of failed endodontic treated mature permenant tooth
Healthy patients
Age of 10 years to 18 years

Exclusion criteria:

Medically compromised patients
Mentally compromised patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided