Evaluation for Healing of Iatrogenic Perforation After No... | NCT06991569

Studies
Evaluation for Healing of Iatrogenic Perforation After Non Surgical Repair

NCT06991569

Sponsor

Mohamed Salah Elwakeel

Status

Completed

Last Update Posted

May 31, 2025Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Root Perforation at the Bifurcation Area
Strip Perforation
Lateral Perforation

Interventions

Non-surgical perforation repair

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

Mar 2025

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

Jan 1, 2023Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

May 9, 2025

First Submission Date that Met QC Criteria

May 18, 2025

First Posted Date

May 28, 2025Actual

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 27, 2025

Last Update Posted Date

May 31, 2025Actual

Name	Class
Ain Shams University	OTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is:

MTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received endodontic treatment with non-surgical root perforation repair by an endodontic specialist in his private practice

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-surgical perforation repair	Procedure	Root perforation repair using MTA or other perforation repair material

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic success in terms of Healing	Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"	7 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who had undergone nonsurgical endodontic perforation repair

Exclusion Criteria:

Teeth that revealed root fracture, inadequate remaining tooth structure, or severe periodontitis
Teeth that had undergone surgical perforation repair

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

subjects were identified from among patients treated by endodontic specialist in his private clinic at Cairo, Egypt

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Endodontic clinic		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided